BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2923864 · Received January 22, 2013

    Report

    Report Number
    3008382007-2013-01176
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 14, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AND REQUESTED BACK.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(6) 2013, ALLEGING INACCURATE ERRATIC READINGS ON HIS ONE TOUCH VERIO PRO METER. THE PATIENT MENTIONED THAT THEY HAD TESTED AND OBTAINED A 250 MG/DL AND A 500 MG/DL. READINGS WERE WITHIN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PATIENT SELF-TREATED WITH INSULIN AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED SINCE THE BACK TO BACK READINGS ARE GREATER THAN 20 % OR 20 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31142 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3366801

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR