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

Lot Number 4350151

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2018, the reporter contacted lifescan (b)(4), alleging that the subject meter read inaccurately erratic.The reporter claimed obtaining blood glucose readings of ¿20, 26, 30, 90 and 95 mg/dl¿ with the subject meter, performed within 20 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for precision.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.

Manufacturer Narrative

The lay user/patients meter have been returned and evaluated by lifescan product analysis with the following findings: the meter passed all testing with no faults found.The reported issue could not be confirmed.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.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 VERIOVUE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7662980
• MDR Text Key: 113168206
• Report Number: 3008382007-2018-01892
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4350151
• Other Device ID Number: 1-32Y1SY9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/17/2018
• Device Age: 15 MO
• Date Manufacturer Received: 06/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1