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

Device Problem Peeled/Delaminated (1454)

Patient Problems Fatigue (1849); Nausea (1970); Anxiety (2328); Shaking/Tremors (2515)

Event Date 07/03/2019

Event Type  Injury  

Event 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: ONE TOUCH ULTRA TEST STRIPS
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 8789109
• MDR Text Key: 150983789
• Report Number: 2939301-2019-02386
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00353885009713
• UDI-Public: 00353885009713
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2019
• Distributor Facility Aware Date: 07/08/2019
• Event Location: Home
• Date Report to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening