BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1063375 · Received June 19, 2008

    Report

    Report Number
    2939301-2008-01129
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JUNE 7, 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER NO LONGER POWERED ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE PT HAD WITH THE CUSTOMER CARE ADVOCATE (CCA), SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PT BY PHONE. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN ON THREE DAYS BEFORE, AT APPROX 8 AM. WHEN THE PT ATTEMPTED TO TEST THAT MORNING, THE SUBJECT METER ALLEGEDLY DID NOT POWER ON. THE PT DENIED TAKING ANY ACTIONS REGARDING HER DIABETES MGMT AS A RESULT OF THE REPORTED ISSUE. HOWEVER, SOMETIME AFTER THE ALLEGED ISSUE BEGAN, SHE REPORTEDLY STARTED FEELING "WEAK AND AS IF SHE WAS GOING TO FALL." ON THE DAY PRIOR TO ORIGINAL DATE AT APPROX 5PM, SHE CLAIMED SHE WENT TO THE ER (ER) BECAUSE OF THESE SYMPTOMS. IN THE ER, THE PT REPORTED HER BLOOD GLUCOSE WAS CHECKED AND A READING OF "517 MG/DL" WAS OBTAINED ON THE ER/HOSP METER. THE PT CLAIMED SHE WAS TREATED WITH 65 UNITS OF INSULIN (TYPE UNK). THE ER ADVISED THE PT TO CONTACT LFS REGARDING THE PROD ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE BATTERY HAD BEEN REPLACED AND THAT THERE WAS NO MISUSE TO THE SUBJECT METER. THE ISSUE REMAINED UNRESOLVED AT THE END OF TROUBLESHOOTING. REPLACEMENT PRODS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY HAD TO BE TREATED BY AN HCP FOR HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L| R