BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3120407 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12142
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER DISPLAYED AN ¿ER2¿ MESSAGE. PER THE OWNER¿S BOOKLET THIS ERROR MESSAGE COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ERROR MESSAGE APPEARED APPROXIMATELY 3 MONTHS PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION(S). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED METER ISSUE. THE PATIENT REPORTED DEVELOPING A ¿LOW BLOOD SUGAR¿ AND ¿PASSING OUT¿; HOWEVER, THE PATIENT WAS UNABLE TO CONFIRM IF THE SYMPTOMS OCCURRED BEFORE OR AFTER THE METER ISSUE BEGAN. THE PATIENT REPORTED HE WAS TREATED IN THE ER AND RECEIVED ¿12 STITCHED AND MINOR PLASTIC SURGERY¿. IT IS NOT KNOWN IF THE PATIENT¿S BLOOD GLUCOSE WAS TESTED WITH AN ER/HOSPITAL METER AT THE TIME OF HIS ARRIVAL OR IF HE ALSO RECEIVED TREATMENT FOR A LOW BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER DID NOT DISPLAY AN ¿ER2¿ MESSAGE WHEN IT WAS MANUALLY POWERED ON. THE CCA NOTED THAT A BLOOD GLUCOSE TEST WAS NOT PERFORMED AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED A ¿LOW BLOOD GLUCOSE EXCURSION¿ AND THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221916 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3401198

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R