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

Medical Device Problem Code	Defective Component (2292)
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 strip vial has been returned and evaluated by lifescan product analysis with the following findings: the vial failed testing; the reported issue was confirmed.The vial was found to be damaged.Complaints relating to the reported product were evaluated.It was concluded that the number of complaints for the product did not breach thresholds indicative of a systemic issue.On (b)(6) 2018, the lay user/patient contacted lifescan usa, alleging that their ot verio vial was open before the first time use.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 VERIO TEST STRIPS
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8098373
• Report Number: 3008382007-2018-03218
• Device Sequence Number: 11185924
• Product Code: NBW
• UDI-Device Identifier: 00353885009751
• UDI-Public: 00353885009751
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1