BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3203223 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18870
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    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/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION. THE PATIENT TOOK THE ACTION OF CONSUMING MORE FOOD AND/OR DRINK. ONE WEEK AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF FREQUENT URINATION. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE CORRECT, AND THAT SHE HAD NOT REPLACED THE METER¿S BATTERY AS RECOMMENDED BY THE MANUFACTURER. THE ISSUE WAS NOT RESOLVED AS THE PATIENT DID NOT HAVE A NEW REPLACEMENT BATTERY AVAILABLE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT¿S TECHNIQUE WAS INCORRECT BY NOT REPLACING THE METER AS RECOMMENDED BY THE MANUFACTURER. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AFTER THE METER POWER ISSUE OCCURRED. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302236 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening