BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1082174 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01503
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET REC'D THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM, AND IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 21, 2008, THE LAY-USER PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER IS GIVING INACCURATE ERRATIC READINGS. THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED DURING THE INITIAL PHONE CALL ON JULY 23, 2008. ON TWO DAYS PRIOR TO ORIGINAL DATE AT 9 PM, THE PT ALLEGEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "220 AND 78 MG/DL" (ACTUALLY READINGS CONFIRMED IN THE METER'S MEMORY WAS 267 AND 97 MG/DL) WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINS OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL. THE PT INDICATED THAT HE WAS UNSURE OF WHICH READING WAS CORRECT AND TOOK AN AVERAGE OF THE TWO REPORTED BLOOD GLUCOSE READINGS. THE PT THEN ALLEGEDLY INCREASED HIS SLIDING SCALE R INSULIN (UNSPECIFIED DOSE) TO 35 UNITS PER THE LFS METER AVERAGE READING (150 MG/DL). THE PT REPORTEDLY DID NOT EAT ANYTHING AFTER TAKING INSULIN. THE PT INDICATED THAT HE DOES NOT USUALLY EAT ANYTHING AFTER TAKING HIS NIGHTTIME INSULIN DOSE. ON THE NEXT DAY AT 2 AM, THE PT WOKE UP WITH SYMPTOM DESCRIBED AS 'SWEATS". THE PT STATED THAT HIS BLOOD GLUCOSE MUST HAVE BEEN IN THE "40 MG/DL" RANGE. THE PT DID NOT CHECK HIS BLOOD GLUCOSE AT THE TIME OF CONCERN. THE PT ADMINISTERED SELF-TREATMENT WITH ORAL GLUCOSE AND FELT BETTER AFTER 10 MINS. THE PT DID NOT TAKE ANY BLOOD GLUCOSE READINGS IMMEDIATELY AFTER THE REPORTED SYMPTOMS ABATED. IN THE MORNING, THE PT WOKE UP AND OBTAINED A BLOOD GLUCOSE READING OF "101 MG/DL" AND REPORTEDLY WAS FEELING FINE. DURING, TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, THE BLOOD SAMPLE WAS TAKEN FROM APPROVED TESTING SITES, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT HAD SYMPTOM THAT IS SUGGESTIVE OF HYPOGLYCEMIA AFTER HE TOOK INSULIN BASED ON THE READINGS OBTAINED ON THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2807354

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R