MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA TEST STRIPS; GLUCOSE MONITORING SYS/KIT

Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Fatigue (1849); Nausea (1970); Shaking/Tremors (2515)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra blue test strips were peeling and sticking together.The complaint was classified based on the customer care advocate (cca) documentation of the call.The patient reported that the test strips were peeling and sticking together around 9-10 am on (b)(6) 2019.The patient manages his diabetes with humulin insulin (no adjustments).He indicated that because he was unable to obtain a reading, he ate sugar to increase his blood glucose level about 30-45 minutes later.He reported that about an hour later, he felt symptoms of ¿nausea, fatigue, shaking and anxiety¿.He denied receiving any treatment for his symptoms above or beyond the usual routine of diabetes care and management.At the time of troubleshooting, the cca noted that alleged issue occurred before inserting the strip into the meter and more than one test strip from the vial was affected.The issue remained unresolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event, after the alleged issue with peeling and sticking test strips began and he was unable to obtain a reading.

• Brand Name: OT ULTRA TEST STRIPS
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8788399
• Report Number: 3008382007-2019-02783
• Device Sequence Number: 14119908
• Product Code: CGA
• UDI-Device Identifier: 00353885009713
• UDI-Public: 00353885009713
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/15/2019
• 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