BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3130436 · Received May 24, 2013

    Report

    Report Number
    3008382007-2013-13013
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 7, 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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT¿S CAREGIVER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT IS UNABLE TO CODE HIS ONETOUCH ULTRA2 METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH SHOTS (OTHER THAN INSULIN) AND HE DID NOT TAKE ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. IT IS NOT KNOWN IF THE PATIENT TESTED HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. ACCORDING TO THE CSR¿S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF SHAKING AN UNKNOWN TIME LATER. THE REPORTER, HOWEVER, DOES NOT KNOW IF THE PATIENT RECEIVED ANY TREATMENT AFTER THE ALLEGED ISSUE OCCURRED. PER CSR¿S NOTES, THE ALLEGED METER ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231359 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3417678

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening