MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA TEST STRIPS; GLUCOSE MONITORING SYS/KIT

Lot Number	3901094
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	Chest Pain (1776); Headache (1880); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, the lay user/patient contacted lifescan (lfs) to report that his onetouch ultra test strips were bent and peeling.The complaint was classified based on customer care advocate (cca) documentation.The patient reported that the issue occurred ¿2 to 3 weeks¿ prior to contacting lfs.The patient manages his diabetes by self-adjusting his insulin doses and increased the dose of his humalog insulin by 1-2 units during the day and his lantus insulin by 2 units at night in response to the alleged issue.The patient reported that ¿30 minutes¿ after the alleged issue occurred he developed symptoms of ¿headaches, blurred vision, bother with his legs and chest pains¿ and stated that ¿a couple of weeks¿ prior to contacting lfs he visited his doctor, who ¿referred him to another doctor¿.During the call the cca noted that more than one strip in the vial was affected and they were bent and peeling prior to inserting the strip into the meter.The product was replaced and requested back for evaluation.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event after the alleged product issue began.
Additional Manufacturer Narrative
The lay user/patients test strips have been returned and evaluated by lifescan product analysis with the following findings: the test strips passed all testing with no faults found.The reported issue could not be confirmed.Lifescan conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT ULTRA TEST STRIPS
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6231579
• Report Number: 3008382007-2017-00872
• Device Sequence Number: 16354049
• Product Code: NBW
• UDI-Device Identifier: 00353885009720
• UDI-Public: (01)00353885009720(10)3901094(17)170430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K043197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 3901094
• Other Device ID Number: 1-AV-1546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2017
• Supplement Report FDA Received Date: 03/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 66 YR
• Patient Weight: 73