BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4832445 · Received June 10, 2015

    Report

    Report Number
    2939301-2015-23578
    Event Type
    Injury
    Date Received
    June 10, 2015
    Report Date
    June 2, 2015
    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
    IL, 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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER DISPLAYED AN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ERROR MESSAGE ¿STRIP ERROR - RETEST WITH A NEW STRIP¿ FIRST OCCURRED ON ¿THE MORNING OF (B)(6) 2015¿. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. HE DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF OBTAINING THE ALLEGED ERROR MESSAGE. HE ALLEGED THAT ¿IMMEDIATELY¿ AFTER THE START OF THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS OF ¿SHAKINESS AND PAIN FROM POKING FINGER¿. HE DENIED RECEIVING ANY TREATMENT FOR HIS SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT HAD BEEN USING THE METER FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ISSUE AND THE ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED ERROR MESSAGE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379845 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3708178

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Life Threatening