BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060366 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01059
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 24, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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/PATIENT CONTACTED LIFESCAN ALLEGING AN INACCURACY WITH THE ONETOUCH ULTRAMINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CORRESPOND WITH THE PATIENT BY PHONE. THE MAS MAILED A LETTER TO THE PATIENT ON JUNE 11, 2008. THE PATIENT STATED THAT THE INACCURACY WITH THE METER STARTED ON FOUR DAYS PRIOR TO ORIGINAL DATE AT 12:48PM. THE PATIENT REPORTEDLY OBTAINED A READING OF "62MG/DL" ON THE ALLEGED METER AND WHEN SHE WAS ABOUT TO TAKE THE ORANGE JUICE, SHE WENT INTO "SEIZURES." ON THE SAME DAY AT 1PM, THE CUSTOMER CALLED IN FOR THE AMBULANCE AND WAS TAKEN TO THE CLINIC WHERE SHE WAS TREATED WITH IV GLUCOSE. THE PATIENT ALSO STATED THAT THE NURSE OBTAINED A READING OF "97MG/DL" AT 1:27 PM ON THE ALLEGED METER AND WAS TESTED "52MG/DL" ON THE CLINIC'S METER. BOTH THE READINGS WERE OBTAINED IN A TIME DIFFERENCE OF 10 MINUTES. BASED ON THE STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDED THE EXPECTED VALUE OF < = 30% AND /OR < =30 MG/DL. DURING THE TROUBLESHOOTING, THE CCA FOUND OUT THE FOLLOWING: THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. IN ADDITION, THE METER READINGS OF "62MG/DL AND 97MG/DL" WERE VERIFIED IN THE METER'S MEMORY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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 2735789

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening