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

Lot Number	4481446
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See incident description for device evaluation.
Event or Problem Description
Device evaluation: 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 reported issue was confirmed.The test strips were found to have scrap top tape over the electrodes.On (b)(6) 2019, the reporter contacted lifescan usa alleging that ¿some¿ of the patient¿s onetouch ultra test strips didn't ¿have black and white strips on the strip, only blue label¿.This complaint was initially ruled our because information obtained during the initial call did not reasonably suggest a malfunction had occurred.There was no allegation of an adverse event as a result of the reported issue.

• 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: 8702771
• Report Number: 3008382007-2019-02153
• Device Sequence Number: 1821781
• Product Code: CGA
• UDI-Device Identifier: 00353885009720
• UDI-Public: 00353885009720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/07/2019

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 4481446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1