BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 4091190 · Received September 16, 2014

    Report

    Report Number
    2939301-2014-24376
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 11, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Product Problem
    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) AND ALLEGED THEIR OT ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ISSUE BEGAN APPROXIMATELY A YEAR AGO, WHEN SHE OBTAINED INACCURATE ERRATIC RESULT(S), THE PATIENT WAS UNABLE TO RECALL THE RESULT(S) OF THE METER. THE PATIENT MANAGES HER DIABETES WITH PILLS, DIET AND/OR EXERCISE. THE PATIENT CONFIRMS SHE TOOK HER USUAL DOSE OF MEDICATION IN RESPONSE TO THE PRODUCT ISSUE (METFORMIN). THE PATIENT ALSO DENIED THAT SHE DEVELOPED SYMPTOMS AS A RESULT OF THE ISSUE; HOWEVER THE PATIENT REPORTED VISITING DOCTOR¿S OFFICE ON AN UNSPECIFIED DATE/TIME. THE PATIENT REPORTED HER BLOOD GLUCOSE WAS TESTED AT THE TIME OF THE VISIT; HOWEVER, SHE DID NOT RECALL THE RESULT. THE PATIENT INFORMED THE CCA THAT SHE WAS ADVISED BY HCP TO GET ANOTHER METER. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE CORRECT SAMPLE SITE WAS USED FOR TESTING METHOD AND STORAGE WERE CORRECT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE SUBJECT METER CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572856 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR