BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1242332 · Received November 21, 2008

    Report

    Report Number
    2939301-2008-03195
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONETOUCH ULTRASMART METER WAS GIVING INACCURATE ERRATIC RESULTS. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON NOVEMBER 20, 2008 AND VERIFIED THE FOLLOWING INFO. THE PT INDICATED THAT HE HAD BEEN GETTING ERRATIC READINGS ON THE ALLEGED METER FOR A FEW DAYS PRIOR TO CALLING LFS. HE WAS ALLEGEDLY UNABLE TO RECALL ANY BLOOD SUGAR READINGS THAT HE THOUGHT WERE INACCURATE. ON THE DAY PRIOR TO ORIGINAL DATE, HE HAD TESTED HIS BLOOD SUGAR AT AROUND 6:00 AM AND 9:30 AM. HE WAS UNABLE TO RECALL READINGS RECEIVED. HE MENTIONED THAT HE HAD ADMINISTERED A BOLUS DOSAGE OF NOVALOG INSULIN BASED ON THE READING REC'D THAT MORNING. HE WAS UNABLE TO RECALL APPROXIMATE TIME WHEN HE ADMINISTERED BOLUS DOSAGE THROUGH INSULIN PUMP. HE WAS ALSO UNABLE TO RECALL HOW MUCH INSULIN HE HAD TAKEN. ON THAT DAY AT AROUND 11:00 AM, THE PT ALLEGEDLY PASSED OUT. THE PARAMEDICS WERE CALLED. HE WAS TREATED WITH GLUCOSE AND FELT BETTER AFTERWARDS. HE MENTIONED THAT HE IS HYPERSENSITIVE TO INSULIN AND RESPONDS TO HIGHER AMOUNT OF INSULIN VERY QUICKLY. A PT REPORTED BLOOD GLUCOSE RESULTS OF "233 MG/DL" WITH A LIFESCAN METER AND "257 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=30%. THE COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT ALLEGED RECEIVING INACCURATE ERRATIC READING ON THE ALLEGED METER. HE REPORTEDLY ADJUSTED BOLUS DOSAGE OF INSULIN BASED ON AN UNK READING REC'D ON THE ALLEGED METER AND LATER, ALLEGEDLY PASSED OUT, WHICH COULD BE SYMPTOMS ASSOCIATED WITH SEVERE HYPOGLYCEMIA. DIABETES CARE MGMT: THE PT NORMALLY TESTS HIS BLOOD SUGAR 6-8 TIMES A DAY EVERY TWO HRS. HE TAKES NOVALOG INSULIN THROUGH INSULIN PUMP.NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2824442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R