BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3014145 · Received March 21, 2013

    Report

    Report Number
    3008382007-2013-05893
    Event Type
    Injury
    Date Received
    March 21, 2013
    Report Date
    February 27, 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
    HI, 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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013. THE PATIENT MANAGES HIS DIABETES WITH NOVOLOG FLEX PEN INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS DOSE OF MEDICATIONS AT THE TIME OF THE ALLEGED ISSUE; HOWEVER, ON (B)(6) 2013 AT 2 PM, THE PATIENT REPORTEDLY TOOK LESS FOOD AND/ OR DRINK. SYMPTOMS WERE NOT SPECIFIED AT THAT TIME; HOWEVER, THAT SAME AFTERNOON, EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "31, 45 AND 50 MG/DL" WITH A LABORATORY DEVICE. THE PATIENT WAS ADMINISTERED FLUIDS INTRAVENOUSLY (TYPE NOT SPECIFIED). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED AND THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT WAS NOT ABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT SUGGESTIVE OF A SERIOUS INJURY AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118470 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3356456

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R