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

Lot Number	4112456
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2017, the reporter contacted lifescan usa, alleging sticking test strip.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
Additional Manufacturer Narrative
The lay user/patient¿s test strips have been returned and evaluated by lifescan product analysis with the following findings: the test strips involved with this complaint failed testing.The reported issue was confirmed; the test strips were found to have been contaminated.A secondary issue was also noted during evaluation as the test strips were found to have been bent during slitting and vialling.Additional tests were performed on the test strip vial and the desiccant to check the structural integrity and for a possible moisture issue.The structural integrity of the test strip vial was found to be intact during a gross leak test.The desiccant within the subject vial was found to contain levels of moisture that reflect normal use (as per product labelling).If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO 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: 6495926
• Report Number: 3008382007-2017-17820
• Device Sequence Number: 616457
• Product Code: NBW
• UDI-Device Identifier: 00353885009768
• UDI-Public: (01)00353885009768(10)4112456(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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: 4112456
• Other Device ID Number: 1-SPA5A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 04/15/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1