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U.S. Department of Health and Human Services

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

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT Back to Search Results
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.
 
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Brand NameOT VERIO IQ METER
Type of DeviceGLUCOSE 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 Key3318328
MDR Text Key11234385
Report Number2939301-2013-01493
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110637
Number of Events Reported1
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 Received08/30/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3456486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/12/2013
Date Manufacturer Received08/12/2013
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

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