BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060336 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01085
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 2, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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/PT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THE PT'S ONE TOUCH ULTRAMINI METER WAS DISPLAYING AN "ER5." PER THE ONE TOUCH ULTRAMINI OWNER'S BOOKLET, AN "ER5" MESSAGE APPEARS WHEN THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE REPORTER NINE DAYS LATER, AND OBTAINED THE FOLLOWING INFO. THE PT'S DAUGHTER REPORTED THAT THE ALLEGED ISSUE BEGAN A COUPLE OF DAYS PRIOR TO CONTACTING LFS. ON THE MORNING OF 2008, THE PT WAS ABLE TO TEST SUCCESSFULLY ON THE SUBJECT METER, BUT WHEN SHE ATTEMPTED TO TEST LATER THAT EVENING (TIME UNK), SHE OBTAINED THE ERROR MESSAGE. THE PT REPORTED FEELING OK AT THE TIME THE ALLEGED ISSUE BEGAN AND PROCEEDED WITH TAKING 70 UNITS OF 75/25 INSULIN (ON A SLIDING SCALE), ATE A REGULAR MEAL, AND THEN WENT TO SLEEP. IN 2008, BETWEEN 1-2 AM, A FEW HOURS AFTER THE REPORTED ISSUE BEGAN, THE PT CLAIMED WAKING UP FEELING "CLAMMY AND HAVING COLD SWEATS." THE PT TREATED HERSELF WITH ORANGE JUICE AND A PIECE OF CHOCOLATE AND REPORTED FEELING BETTER AFTERWARDS. THAT SAME MORNING, AT 10:30 AM, THE PT ATTEMPTED TO TEST AGAIN WITH THE SUBJECT METER BUT CONTINUED TO OBTAIN AN "ER5" MESSAGE. THE REPORTER CONFIRMED HER MOTHER WOKE UP WITH "BLURRED VISION" BUT TOOK NO ACTION REGARDING THIS SYMPTOMS OTHER THAN REST. AFTER OBTAINING THE ERROR MESSAGE FOR THE SECOND TIME ON THE SUBJECT METER, THE REPORTER CLAIMS HER MOTHER DID TEST ON A NON-LFS METER AND OBTAINED READINGS OF "65 AND 104 MG/DL." AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO CONFIRM THAT THE TEST STRIPS WERE IN GOOD CONDITION AND THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUE. THE ERROR MESSAGE WAS RESOLVED WHEN THE PT TESTED WITH A DIFFERENT VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS 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 ALLEGED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE REPORTED 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 59 YR Life Threatening| R