BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO SYNC METER

    MDR report key: 5139725 · Received October 9, 2015

    Report

    Report Number
    2939301-2015-42990
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Report Date
    October 1, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K120708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO SYNC METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT COULD NOT RECALL WHEN THE ALLEGED INACCURACY OCCURRED BUT STATED THAT THEY HAD OBTAINED BLOOD GLUCOSE READINGS OF "239, 103, 262 AND 176MG/DL" WITH THE SUBJECT METER AND A RESULT OF "102MG/DL" ON ANOTHER "VERIO" METER WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (UNSPECIFIED DOSAGES OF NOVOLOG AND LANTUS), AND DENIED MAKING ANY CHANGES TO THEIR DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. "SEVERAL DAYS" AFTER OBTAINING THESE ALLEGED INACCURATE RESULTS THE PATIENT CLAIMS TO HAVE "LOST FEELING IN BOTH LEGS" AND ALSO BECAME "NUMB." IN RESPONSE TO THESE SYMPTOMS THE PATIENT SELF-TREATED BY TAKING A "1:20 RATIO" OF INSULIN OVER THE COURSE OF SEVERAL DAYS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT WAS UNABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID THEY RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE SOME OF THE ALLEGED GLUCOSE RESULTS EXCEED LFS'S CRITERIA FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671128 OT VERIO SYNC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1