BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2841127 · Received November 21, 2012

    Report

    Report Number
    3008382007-2012-06515
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 2, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE 510K IS K110637.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE HEALTHCARE PROFESSIONAL/REPORTER CONTACTED LIFESCAN (LFS) IN (B)(4) ON BEHALF OF THE PATIENT ALLEGING THE ONETOUCH VERIO IQ METER WAS DISPLAYING A BATTERY INDICATOR. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE REPORTER ALLEGED THE METER WAS DISPLAYING A BATTERY INDICATOR. THERE IS NO INDICATION THAT SUBJECT METER CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

    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 3270030

    Patients

    Seq Age Sex Outcome Treatment
    1