BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1040237 · Received May 7, 2008

    Report

    Report Number
    2939301-2008-00690
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 17, 2008
    Report Date
    February 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO OBTAIN AND VERIFY INFO; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. THE SMAS SENT A LETTER REQUESTING THE PT CONTACT MEDICAL AFFAIRS. ON THREE DAYS EARLIER, THE PT OBTAINED A 'HIGH' PRE-DINNER BLOOD GLUCOSE READING ON THE REPORTED METER; SHE DID NOT SPECIFY THE EXACT RESULT. BASED ON THIS READING, THE PT TOOK AN INCREASED DOSE OF HUMALOG INSULIN. ONE HR AFTER DINNER, THE PT EXPERIENCED THE SYMPTOMS OF SWEATING, SHAKING AND WEAKNESS. WHILE SYMPTOMATIC, THE PT TESTED HER BLOOD GLUCOSE LEVEL AND OBTAINED THE READING OF 104 MG/DL ON THE REPORTED METER. FIVE MINUTES LATER, THE PT OBTAINED A BLOOD GLUCOSE RESULT OF 49 MG/DL, USING A BACKUP METER. THE PT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS. SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PT TAKES HUMALOG 50/50 INSULIN 12 UNITS TWICE PER DAY. IT WOULD HAVE BEN HELPFUL TO DETERMINE THE SPECIFIC RESULT OBTAINED THAT WAS 'HIGH', THE INCREASED DOSE OF INSULIN TAKEN, HER EXPECTED READINGS, THE READINGS OBTAINED PRIOR TO THIS EVENT, AND IF THE PT ROUTINELY ADJUSTS HER INSULIN DOSES BASED ON METER READINGS. THE CUSTOMER CARE ADVOCATE DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THAT THE PT'S TESTING TECHNIQUE WAS CORRECT, THE TEST STRIPS WERE WITHIN EXPIRATION DATING AND IN GOOD CONDITION, AND THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE AND CALIBRATION CODE #. QUALITY CONTROL TESTING WAS PERFORMED DURING THE CALL WITH FAILING RESULTS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PT CLAIMED SHE BECAME HYPOGLYCEMIC AFTER TAKING INCREASED DOSE OF INSULIN BASED ON HER METER READING. THE PT REC'D TREATMENT WITH GLUCOSE TO RESOLVE HER SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2807313

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R