BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3103348 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10777
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WOULD POWER OFF DURING USE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT NOTED THE REPORTED METER WOULD POWER OFF DURING USE; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING AND EXHAUSTION. THE PATIENT'S HCP ADMINISTERED THE TREATMENT OF ADJUSTING THE PATIENT'S INSULIN REGIMEN. TROUBLESHOOTING REVEALED THERE HAD BEEN NO MISUSE OF THE PRODUCT, AND THE METER'S BATTERY DID NOT NEED TO BE RECHARGED. THE ISSUE WAS NOT RESOLVED. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER POWER ISSUE OCCURRED, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203398 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 Life Threatening| R