BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3952337 · Received July 23, 2014

    Report

    Report Number
    2939301-2014-18280
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 15, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN AROUND (B)(6) 2014 OR (B)(6) 2014. THE PATIENT DID NOT SPECIFY RESULTS OBTAINED WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). BASED ON THE REPORTED ISSUE, THE PATIENT REPORTEDLY ADMINISTERED HIMSELF HUMALOG INSULIN (AMOUNT NOT SPECIFIED). THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS DUE TO THE REPORTED ISSUE; HOWEVER, SPECIFICS SYMPTOMS WERE NOT PROVIDED. TREATMENT IN RESPONSE TO HIS ALLEGED SYMPTOMS WAS ALSO NOT SPECIFIED. THE PATIENT DENIED TESTING WITH ANOTHER DEVICE. 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 REPORTEDLY MAY HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430930 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening