BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3141623 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14258
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2013, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH VERIO IQ METER HAS A POWER ISSUE (UNIT POWER OFF DURING USE). THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT¿S DIABETES IS MANAGED WITH INSULIN, NO ADJUSTMENT. THE POWER ISSUE BEGAN ON (B)(6) 2013 AT 7AM. ONE HOUR LATER, THE PATIENT REPORTED HAVING SYMPTOMS OF DIZZINESS. THERE WAS NO TREATMENT TO SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT WAS EDUCATED ON THE SUBJECT METERS BEHAVIOR AND AUTO-SHUTOFF FEATURE BUT THE ISSUE WAS NOT RESOLVED. THERE WAS PRODUCT MISUSE. BASED ON THE INFORMATION, THE METERS BATTERY DID NOT REQUIRE RECHARGE. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED POWER ISSUE. THE PATIENT DID NOT HAVE ANY SYMPTOM THAT MEET LIFESCAN¿S CRITERIA OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244547 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR