BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2801669 · Received October 23, 2012

    Report

    Report Number
    3008382007-2012-05430
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 30, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE PRODUCT(S) HAVE NOT YET BEEN EVALUATED; LFS WILL EVALUATE IT/THEM AND INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. NO CURRENT LEAKAGE WAS OBSERVED AT THE SLEEPING MODE. THE METER WAS FOUND TO FUNCTION PROP`ERLYIF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE USB CABLE HAVE PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. HOWEVER, THE AC ADAPTER HAD DEFECTIVE COMPONENTS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: USB CABLE, AC ADAPTER: 10/11/2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) FROM THE UNITED STATES ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS PROMPTING A BATTERY INDICATOR SYMBOL WHEN THEY ATTEMPTED TO TEST THEIR BLOOD GLUCOSE. PER THE ONETOUCH VERIO IQ PRODUCT MANUAL THE BATTERY INDICATOR PROMPTS WHEN THE BATTERY NEEDS TO BE REPLACED IN THE METER. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THEIR COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT CLAIMED THAT THE SUBJECT METER WAS PROMPTING A BATTERY INDICATOR WHEN THEY ATTEMPTED TO TEST THEIR BLOOD GLUCOSE. THERE IS NO EVIDENCE THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT 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 3237615

    Patients

    Seq Age Sex Outcome Treatment
    1