MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOFINE 8 MM (30G); NEEDLE

Catalog Number 185250

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Reaction (2414)

Event Date 02/11/2012

Event Type  Injury  

Event Description

Skin reaction around injection site.Rash, inflammation and red [injection site erythema].Skin reaction around injection site.Rash, inflammation and red [injection site rash].Skin reaction around injection site.Rash, inflammation and red [injection site inflammation].Case description: does the incident represent a serious public hlth threat? no.This spontaneous case from (b)(6) was reported by a consumer as "skin reaction as injection site.Rash, inflammation and red." and concerns (b)(6) year-old male pt treated with levemir flexpen (insulin determir) from (b)(6) 2012 and novofine 8 mm (30g) (needle) for type ii diabetes mellitus.Pt's height: not reported.Med history includes type 2 diabetes mellitus (duration unk).The pt had reportedly been taking levemir flexpen from (b)(6) 2012 and novofine 8 mm (30g) (needle) from an unk date.On (b)(6) 2012, the pt experienced skin reaction around injection site - rash, inflammation and redness.The pt had to visit a dermatologist.Action taken to levemir flexpen was reported as product discontinued due to adverse event.The doctor stopped levemir and started on lantus (insulin glargine).Actional taken to novofine 8 mm (30g) was not reported.The overall outcome was reported as not yet recovered.

Manufacturer Narrative

Analysis reply: product: novofine g30, 8 mm.Case conclusion: the used needle had a damaged needle point.The observed fault is a result of accidental damage during use product: levemir 3ml flexpen.Lot no.: ap51006.Drug conclusion: cartridge/preparation: a visual examination of the received sample has been performed.Furthermore, trending on the batch has been performed.Nothing abnormal was found.On (b)(6) 2014 a correction was performed.The following has been corrected: -the reported suspect device was corrected from novofine needle unspecified to novofine 8 mm (30g).Final comment from the mfr: (b)(4) 2012: the suspected novofine 30 g needle was returned to novo nordisk a/s and investigations showed that the needle tip was blunted, this was most likely due to re-use of the needle.The experienced adverse events is most likely caused by basal insulin used (levemir) and not the blunted needle and a search in novo nordisk a/s safety data base found no similar cases to argus case (b)(4) with respect to novofine 30 g needles.Evaluation summary: microscopical examinations performed.The used needle had a damaged needle point.Needle points are very delicate and should be handled very carefully to avoid damage prior to or during use.

• Brand Name: NOVOFINE 8 MM (30G)
• Type of Device: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd 2880 ; DA 2880
• Manufacturer Contact: novoprod ; p.o. box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 3876326
• MDR Text Key: 15365010
• Report Number: 9681821-2014-00026
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Type of Report: Initial
• Report Date: 03/07/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 185250
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2012
• Initial Date FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR