BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2905849 · Received January 10, 2013

    Report

    Report Number
    3008382007-2013-00565
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 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
    UK
    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 (LFS) (B)(4) ALLEGING HIS ONETOUCH ULTRA2 METER DISPLAYED AN UNKNOWN 'ERROR' MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT A MONTH PRIOR TO CONTACTING LFS. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES OR IF CHANGES WERE MADE TO HIS USUAL MANAGEMENT ROUTINE. ON (B)(6) 2013, THE PATIENT CLAIMS HE FELT A LOW BLOOD GLUCOSE SYMPTOM OF SWEATING. THE PATIENT REPORTEDLY TOOK MORE FOOD AND/ OR DRINK. IT IS NOT KNOWN IF THE PATIENT TESTED WITH ANOTHER DEVICE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14427 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3361731

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R