BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2893903 · Received January 3, 2013

    Report

    Report Number
    3008382007-2013-00011
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 21, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/13/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 AND (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING AND FUNCTIONED PROPERLY; NO FAULTS WERE FOUND. THE TEST STRIPS ALSO 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH VERIO METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HER BLOOD GLUCOSE 8X DAILY AND HER RESULTS ARE USUALLY AROUND "5-10 MMOL/L." THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN THROUGH PUMP THERAPY. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 1000AM. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "9.6 MMOL/L" WITH THE SUBJECT METER. ABOUT 10 MINUTES PRIOR TO TESTING, THE PATIENT CLAIMS SHE FELT LOW BLOOD GLUCOSE SYMPTOMS OF TIRED, DIZZY AND SHAKY. THE PATIENT REPORTEDLY "TOOK A BIT OF SOFT DRINK AND SOME COOKIES" AS TREATMENT AND FELT BETTER ABOUT 15-30 MINUTES AFTER. PRIOR TO THE ONSET OF HER SYMPTOMS, THE PATIENT DID NOT RECALL HER PREVIOUS BLOOD GLUCOSE RESULTS OR IF CHANGES WERE MADE TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT DENIED TESTING WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3296974

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR