BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1001982 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00215
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE PT STATED HE TYPICALLY GETS METER READINGS IN THE "130'S MG/DL" WHEN HE FIRST WAKES UP BUT WHEN HE WOKE UP ON FOUR DAYS EARLIER APPROX 8AM, HE GOT A "215 MG/DL" METER READING. BASED ON THE METER READING/SLIDING SCALE, HE TOOK 10 UNITS OF HUMALOG. HE RECALLED THAT AFTER HE TOOK THE INSULIN, HE DRANK COFFEE BUT FORGOT TO EAT BREAKFAST THAT MORNING. ABOUT AN HOUR LATER, HE STARTED TO SEE SPOTS AND HAD BLURRED VISION. HE RETESTED HIS BLOOD GLUCOSE AND GOT A METER READING "OVER 200 MG/DL." HE WAS SURPRISED THAT THIS BLOOD GLUCOSE LEVELS WERE STILL HIGH AND TOOK ANOTHER 10 UNITS OF HUMALOG WANTING TO GET HIS BLOOD GLUCOSE LEVELS DOWN. ABOUT 15-20 MINUTES AFTER HE TOOK HIS SECOND SHOT OF INSULIN, THE PT WAS REPORTEDLY TALKING IN SUCH A WAY WHERE HIS BROTHER WAS UNABLE TO UNDERSTAND HIM AND THEN HE EVENTUALLY PASSED OUT. HIS NEIGHBOR, WHO IS ALSO A NURSE, TESTED HIS BLOOD GLUCOSE ON HER METER AND GOT "29 MG/DL." APPROX 10:30 AM THE SAME DAY, THE PARAMEDICS CAME. HE WAS TREATED WITH IV GLUCOSE AND THEN TAKEN TO THE HOSPITAL TO STABILIZE HIS BLOOD GLUCOSE LEVELS WITH FOOD AND THEN RELEASED AN HOUR LATER. THE PT STATED THAT HE WAS TESTED ON THE PARAMEDIC AND HOSPITAL'S METERS BUT HE WAS UNABLE TO REPORT THE RESULTS. THE CUSTOMER CARE ADVOCATE (CCA) OBTAINED THE FOLLOWING METER READINGS, "445, 215, 231, 217, AND 292 MG/DL" FROM THE METER'S MEMORY BUT THE DATES/TIMES OF THE RESULTS WERE NOT NOTED. THE CCA VERIFIED THAT THE METER WAS CORRECTLY SET TO "MG/DL," AN APPROVED SAMPLE SOURCE WAS USED, AND THE CORRECT TESTING/CLEANING TECHNIQUES WERE USED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED HE PASSED OUT AFTER TAKING INSULIN BASED ON HIS METER READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2718862

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R