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

Lot Number	4243720
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Sweating (2444)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultra test strips were peeling.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that she first noticed that the test strips were peeling at 7:00pm on (b)(6) 2017; the alleged issue occurred when the test strips was inserted into the test strip port of the meter.The patient manages her diabetes with oral medication, diet and/or exercise.She denied making any changes to her usual diabetes management regimen as a result of the alleged issue.She reported that one day after the issue began, she developed symptoms of ¿headache, sweating and tired¿.She denied receiving any treatment for her symptoms above and beyond her usual diabetes care and management routine.At the time of troubleshooting, the cca noted that the patient was using the correct testing steps.The alleged issue occurred after inserting the strip into the meter.The cca walked the patient through inserting a new test strip and the issue was resolved.Replacement test strips were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms suggestive of a serious injury adverse event, i.E.Headache, sweating and tired, after the alleged issue with peeling test strips began.

• 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: 6896588
• Report Number: 3008382007-2017-22670
• Device Sequence Number: 706694
• Product Code: NBW
• UDI-Device Identifier: 00353885994255
• UDI-Public: (01)00353885994255(10)4243720(17)190131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/15/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 4243720
• Other Device ID Number: 1-AV-1546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 09/27/2017
• 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: 58 YR
• Patient Weight: 75