BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2871945 · Received December 13, 2012

    Report

    Report Number
    3008382007-2012-08084
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 20, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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) ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THIS COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT ON (B)(6) 2012 SHE DEVELOPED SYMPTOMS OF "SHAKY AND SWEATY". IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A RESULT OF "120 MG/DL". THE PATIENT STATED SHE DID NOT FEEL THE READING WAS CORRECT, SO SHE RETESTED WITH ANOTHER DEVICE (OT ULTRA2) AND OBTAINED A READING OF "80 MG/DL", WHICH SHE FELT CORRELATED WITH HER FEELINGS. IN RESPONSE TO THE SYMPTOMS THE PATIENT CLAIMED SHE TREATED HERSELF WITH GLUCOSE TABLETS AND CONFIRMED FEELING BETTER AFTERWARDS. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT DID NOT RECALL WHEN SHE HAD LAST TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER. THE PATIENT INFORMED THE MSS THAT SHE TAKES A SET DOSE OF LANTUS INSULIN IN THE MORNING AND A SET DOSE OF NOVOLOG INSULIN WITH HER MEALS. THE PATIENT CONFIRMED THAT SHE DID NOT MAKE ANY ADJUSTMENTS TO HER INSULIN DOSE IN RESPONSE TO AN ALLEGED HIGH READING OBTAINED WITH THE SUBJECT METER. AT THE TIME OF TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT RAN A CONTROL SOLUTION ON THE SUBJECT METER AND TEST STRIPS AND THE RESULT FELL WITHIN THE SPECIFIED CONTROL RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED AND/OR CONTRIBUTED TO THE SERIOUS INJURY. THE PATIENT WAS ALREADY SYMPTOMATIC AT THE TIME SHE OBTAINED THE ALLEGED INACCURATE HIGH RESULT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE RESULT OBTAINED WITH THE SUBJECT METER DID NOT CORRELATE WITH THE PATIENT'S SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3247713

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR