BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2923596 · Received January 22, 2013

    Report

    Report Number
    3008382007-2013-01116
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "147 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DOSE OF MEDICATIONS. THE PATIENT DENIED DEVELOPING SYMPTOMS; HOWEVER, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "23 MG/DL" WITH ANOTHER DEVICE. THE PATIENT DRANK JUICE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "23 MG/DL" WITH ANOTHER DEVICE WHICH IS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30541 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3329242

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R