BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3181159 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17920
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 30, 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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AROUND 130PM. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF ¿112 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN AND LANTUS INSULIN. BASED ON THE ALLEGED RESULT, THE PATIENT REPORTEDLY ADMINISTERED SELF AN INCREASED DOSE OF HUMALOG INSULIN (5 UNITS). A LITTLE OVER AN HOUR LATER, THE PATIENT CLAIMED SHE FELT DIAPHORETIC, ¿FELT LIKE SHE WAS GOING TO DIE,¿ COULD NOT THINK AND HAD DIFFICULTY MOVING. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMINISTERED INTRAVENOUS FLUIDS (TYPE NOT SPECIFIED). THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿159 MG/DL¿ WITH THE ER/ HOSPITAL METER. 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283287 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3301908

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R