BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060279 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01045
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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

    IN 2008 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER HAD A CODING ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PT TO OBTAIN ADD'L INFO. THE PT TESTS HIS BLOOD GLUCOSE ONCE PER DAY BEFORE HAVING BREAKFAST AND MANAGES HIS DIABETES WITH PILLS, DIET AND EXERCISE. THE REPORTER STATED THAT THE "CALCODE MISSING" ISSUE FIRST OCCURRED A COUPLE OF MONTHS AGO (EARLY 2008), AND THE PT GAVE UP ON TESTING WITH THE SUBJECT METER BECAUSE HE WAS "UNSURE HOW TO USE THE METER." THE PT DID NOT MAKE ANY CHANGES IN TERMS OF HIS DIABETES TREATMENT OR SEEK ANY MEDICAL INTERVENTIONS AFTER THE REPORTED ISSUES WITH THE METER. HE ALSO REPORTS NOT HAVING ANY SYMPTOMS AFTER THE ALLEGED METER ISSUE. HOWEVER, ON TWO DAYS PRIOR TO ORIGINAL DATE AT NIGHT OR THE NEXT DAY IN THE MORNING, THE REPORTER CALLED FOR THE EMERGENCY MEDICAL SERVICES (EMS) BECAUSE THE PT WAS GOING THROUGH "DIABETIC SEIZURE." THE PT WAS NOT TESTED ON THE SUBJECT METER PRIOR TO GOING TO THE HOSPITAL OR MADE ANY CHANGES IN TERMS OF HIS DIABETES TREATMENT. THE REPORTER STATED THAT SHE WOULD HAVE GIVEN THE PT SOMETHING TO EAT IF SHE HAD KNOWN HE WAS THAT "LOW". THE PT WAS TESTED ON THE HOSPITAL METER WITH A RESULT OF "47 MG/DL" AND HE WAS TREATED WITH IV GLUCOSE DURING HIS STAY IN THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PT HAD THE METER SINCE EARLY 2008; HOWEVER, HE WAS NOT ABLE TO TEST BECAUSE OF A REPORTED CAL CODE ISSUE. THE CUSTOMER SERVICE REP (CSR) WALKED THE LAY USER/REPORTER THROUGH TROUBLESHOOTING AND THE ISSUE WAS RESOLVED. ALTHOUGH THE ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED, BECAUSE THE PT ALLEGED NOT BEING ABLE TO TEST HIS BLOOD SUGAR FOR A COUPLE MONTHS, AND THEN HOSPITALIZED FOR SEVERE HYPOGLYCEMIA WITH SEIZURE. THE PT'S PRODUCTS ARE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2793452

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R