BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1192391 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02534
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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, A PT/LAYPERSON ALLEGED THAT HER ONETOUCH ULTRA METER RESULTS WERE INACCURATELY LOW. THE PT HAD COMPARED HER METER TO A FRIEND'S ACCUCHEK, 491 VS 500'S (POSSIBLY 9/14). THE PT INJECTED 25 UNITS HUMALOG WITH NO ADVERSE EFFECT. ON 9/16, THE PT REPORTEDLY BECAME SWEATY AFTER INJECTING 25 UNITS OF HUMALOG BASED ON HER METER'S 381 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE LEARNED THE METER WAS SET TO CODE 3 WHILE THE TEST STRIPS WERE CODE 9. THE METER AND STRIPS WERE REPLACED. THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT ON TWO DAYS LATER, AND HAS CLASSIFIED THE COMPLAINT BASED UPON HER COMMENTS. THE PT INDICATED SHE WAS UNSURE WHETHER THE METER'S RESULTS WERE INACCURATELY HIGH OR LOW. SHE CONCURRED THAT THE METER WAS MISCODED AND POSSIBLY WAS MISCODED ON EIGHT DAYS PRIOR TO ORIGINAL DATE SINCE SHE WAS UNAWARE OF THAT PROCESS. ON THAT DAY, THE PT BELIEVES SHE TOOK HUMALOG IN THE MORNING ALONG WITH HER A.M. 15 UNITS NPH, AND AT LUNCH. AROUND 7 OR 7:30 P.M. BEFORE EATING A LARGE DINNER, THE PT INJECTED 25 UNITS OF HUMALOG BASED ON A 381 BLOOD GLUCOSE. APPROX 30 TO 45 MINS LATER, THE PT THOUGHT SHE WAS GOING TO PASS OUT, BEGAN SWEATING, AND BECAME LETHARGIC. HER DAUGHTER OBTAINED "31" MG/DL ON THE METER AND GAVE HER PURE PEANUT BUTTER UNTIL HER BLOOD GLUCOSE ROSE TO 170 MG/DL. BECAUSE THE PT HAD NEVER CODED THE METER THAT DID NOT MATCH THE STRIP CODE, THE RESULTS PRESUMABLY WERE INACCURATE. THE PT FOLLOWED THE SLIDING SCALE, THE PHYSICIAN RECOMMENDED AND INJECTED 25 UNITS BASED UPON HER ELEVATED BLOOD GLUCOSE. ALTHOUGH THE PT DID NOT ALLEGE HARM DUE TO THE USE OF THE METER, A FAMILY MEMBER TREATED THE PT DUE TO HER HYPOGLYCEMIC SYMPTOMS AND REPORTEDLY OBTAINED A METER RESULT OF 31 MG/DL. FOR THESE REASONS, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2768383

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R