BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2863570 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07369
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT DID NOT RECALL WHEN THE ALLEGED POWER ISSUE STARTED. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE POWER ISSUE. APPROXIMATELY 4 HOURS AFTER THE ISSUE STARTED THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF "DRY MOUTH, SPOTS ON EYES AND COULD HARDLY TALK". THE PATIENT STATED THAT ON THE EVENING OF (B)(6) 2012 SHE WAS SEEN IN THE ER AND WAS TREATED WITH AN "AMARYL" SHOT AFTER SHE OBTAINED A BLOOD GLUCOSE RESULT OF "575 MG/DL" WITH AN ER/HOSPITAL METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT HAD NOT REPLACED THE SUBJECT METER'S BATTERY AS RECOMMENDED IN THE OWNER¿S BOOKLET. THE PATIENT DID NOT HAVE A NEW BATTERY WITH HER AT THE TIME OF THE CALL. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SIGNS/SYMPTOMS AND WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED METER POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 2701628

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R