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

Lot Number 4369481

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

See incident description for device evaluation.

Event Description

The lay user/patients test strips have been returned and evaluated by lifescan product analysis with the following findings: the test strips failed testing.The test strips appear to have been contaminated with excess adhesive.Complaints relating to the reported product(s) were evaluated.It was concluded that the number of complaints for the product(s) did not breach thresholds indicative of a systemic issue.On (b)(6) 2018, the lay user/patient contacted lifescan usa, alleging that the subject ot ultra blue test strips were sticking together.This complaint was initially ruled out because during customer services troubleshooting, there was no indication to reasonably suggest that the product malfunctioned and there was also no allegation of an adverse event as a result of the reported issue.

• Brand Name: OT ULTRA TEST STRIPS
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8929425
• MDR Text Key: 155520018
• Report Number: 3008382007-2019-03515
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00353885009713
• UDI-Public: 00353885009713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4369481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1