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Owen Mumford insulin pens recalled due to dosage fault

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Patients with diabetes who use insulin pens manufactured by Owen Mumford are being warned by the Medicines and Healthcare products Regulatory Agency to check if they have an affected LOT.

If they have a pen from the list of affected LOTs, then they should stop using them and receive a replacement at the earliest opportunity, warned the MHRA in a medical device alert.

Owen Mumford has initiated a voluntary recall of affected LOTs and this is due to a dosage fault with the pens which could lead to hyperglycaemia if an underdose of insulin is given.

The fault with the four specific pens – Autopen Classic 1 unit pen, Autopen Classic 2 unit pen, Autopen 24 1 unit pen and Autopen 24 unit 2 pen – can cause the dose selector to suddenly revert to zero, potentially leading to people receiving an underdose of insulin or no insulin at all.

The failure rate of these 4,290 devices that have been distributed in the UK is 42%.

Dr Neil McGuire, MHRA clinical director of devices, said: “It is vital that people check if they have these affected pens and should obtain an alternative device before stopping using them.

He added that patients should seek a replacement at the earliest opportunity by contacting Owen Mumford via technical.support@owenmumford.co.uk.

 

MHRA

The affected Owen Mumford insulin pens

 

To identify affected devices still within their packaging, patients and clinicians should look for the following packaging LOT code on the outer carton.

 

Packaging lot codeProduct codeProduct name
7VJAN38103ml 1 Unit Autopen Classic
7WBAN4200Autopen 24 3ml 2 Unit
7WCAN4210Autopen 24 3ml 1 Unit
7WDAN38003ml 2 Unit Autopen Classic
8CNAN4200Autopen 24 3ml 2 Unit
8CPAN4200Autopen 24 3ml 2 Unit
8CRAN4210Autopen 24 3ml 1 Unit
8ELAN38003ml 2 Unit Autopen Classic
8EMAN38103ml 1 Unit Autopen Classic
8JKAN4210Autopen 24 3ml 1 Unit
8JMAN38003ml 2 Unit Autopen Classic
8JNAN38103ml 1 Unit Autopen Classic
8JPAN4210Autopen 24 3ml 1 Unit
8VVAN4200Autopen 24 3ml 2 Unit
8VWAN4200Autopen 24 3ml 1 Unit

 

To identify affected devices without packaging look for the following production LOT codes which can be found on the lower part of the pen body.

 

Production lot code (stamped on pen)Product codeProduct name
7RTAN38103ml 1 Unit Autopen Classic
7PNAN4200Autopen 24 3ml 2 Unit
7PPAN4210Autopen 24 3ml 1 Unit
7RVAN38003ml 2 Unit Autopen Classic
8KKAN38003ml 2 Unit Autopen Classic
8XDAN4200Autopen 24 3ml 2 Unit
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