BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1570954 · Received December 30, 2009

    Report

    Report Number
    2939301-2009-08215
    Event Type
    Injury
    Date Received
    December 30, 2009
    Date of Event
    December 23, 2009
    Report Date
    December 23, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY USER/PT CONTACTED LIFESCAN, ALLEGING THE ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PT TO OBTAIN/CLARIFY INFO. THE PT SAID THAT EARLY IN THE MORNING, SHE OBTAINED A READING OF 149 MG/DL AND AT 8:16 AM, OBTAINED A READING OF 123 MG/DL. SHE THOUGHT THE READINGS WERE PERFECTLY NORMAL SO SHE DID NOT TAKE ANY INTERVENTION BASED ON THE READINGS. SHE SAID THAT HAD THE READINGS HAD BEEN LOWER (AROUND 80 MG/DL), SHE WOULD HAVE EATEN AND IF THEY WERE EVEN LOWER SHE WOULD INGEST A LOT OF GLUCOSE. THE PT SAYS SHE TAKES HUMALOG BASED ON A SLIDING SCALE AND LANTUS ON A SET 35 UNITS PER DAY. SHE SAYS SHE TAKES 7 OR 8 UNITS OF HUMALOG WHEN HER READING IS AROUND 200 OR 250 MG/DL, BUT ALSO VARIES THE DOSE DEPENDING ON WHAT SHE EATS. SHE REPORTEDLY DID NOT TAKE HUMALOG IN THE MORNING OR EAT ANYTHING BECAUSE SHE THOUGHT HER READING WAS NORMAL. FIFTEEN TO TWENTY MINUTES AFTER THE 123 MG/DL READING, THE PT REPORTEDLY PASSED OUT AND HER FRIEND CALLED THE PARAMEDICS. THEY ARRIVED AROUND 8:30 AM AND TREATED THE PT WITH IV GLUCOSE. AT AROUND 8:45 AM, A READING WAS REPORTEDLY TAKEN ON THE PARAMEDICS METER, WHICH WAS REPORTEDLY 27 MG/DL. SHE SAID THAT AT 9:35 AM, THE PARAMEDICS OBTAINED A READING OF 68 MG/DL ON THEIR METER AND 49 MG/DL IN THE PT'S METER. SHE SAID IT TOOK A WHILE FOR HER TO FEEL BETTER AFTER GETTING IV GLUCOSE FROM THE PARAMEDICS, SHE MENTIONS LONGER THAN USUAL WHEN SHE HAS GLUCOSE AS TREATMENT. THE PARAMEDICS ALLEGEDLY TOLD HER TO GET A NEW METER. ACCORDING TO THE TROUBLESHOOTING PREFORMED WITH CUSTOMER SERVICE, THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AT THE TIME OF USING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGES READINGS THAT WERE INACCURATELY HIGH, AND WAS NOT ABLE TO PREVENT SYMPTOMS OF HYPOGLYCEMIA BASED ON THE METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2962543

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R