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

Lot Number 3456486

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2013

Event Type  malfunction  

Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for evaluation. If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.

Manufacturer Narrative

Follow-up (2/18/2014)-device evaluation: the meter involved with this complaint has been returned and evaluated by lifescan product analysis on (b)(4) 2014 with the following findings: the meter has passed testing with no faults found. If lifescan obtains additional information regarding this complaint, a follow up report will be submitted. At this time, lifescan considers this matter closed. The retain lfs products were tested and they passed testing with no faults found.

Event Description

On (b)(6) 2013, the reporter contacted lifescan (b)(4), alleging inaccurate results. The reporter alleged inaccurate high results. The reporter obtained blood glucose results of "5. 6 mmol/l" with a lifescan meter and "8. 5 mmol/l" on another meter, performed within 30 minutes of each other. Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan's criteria for accuracy. This complaint is being reported because the reported results did not meet lifescan¿s accuracy criteria and the alleged inaccuracy issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.

• Brand Name: OT VERIO IQ 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
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 3318328
• MDR Text Key: 11234385
• Report Number: 2939301-2013-01493
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/12/2013

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/30/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 3456486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2013
• Date Manufacturer Received: 08/12/2013
• 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