BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1000995 · Received February 19, 2008

    Report

    Report Number
    2939301-2008-00200
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVAL 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 AT 12:20PM, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER IS GIVING INACCURATE HIGH READINGS AND THE SERIAL NUMBER ON THE METER IS WORN OFF (ILLEGIBLE LABEL). THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO OBTAIN/CLARIFY MORE INFO. ON A WEEK EARLIER AT 6AM, THE PT OBTAINED AN INACCURATE HIGH READING OF "265 MG/DL." THE PT FELT AS THOUGH HIS BLOOD GLUCOSE WAS LOW AND HAD SYMPTOM DESCRIBED AS "TIRED." AT 7 AM, THE PT TOOK HIS USUAL 15 UNITS OF NPH AND 15 UNIT OF REG INSULIN. THE PT ALSO TOOK 1 GLUCOSE TABLET BASED ON HIS LOW SYMPTOM. AT 7:30AM, THE PT WENT OUT TO HAVE BREAKFAST AND PASSED OUT. THE PT INDICATED THAT HIS WIFE WAS DRIVING AT THE TIME OF CONCERN. AT AROUND 7:45AM, THE EMERGENCY SERVICES TESTED THE PT ON THE EMT METER AT "29 MG/DL." THE PT WAS TREATED WITH IV GLUCOSE AND CAME TO AT 8AM. THE PT WAS NOT TAKEN TO THE HOSP. THE EMERGENCY SERVICE ADVISED THE PT TO HAVE SOMETHING TO EAT AND TEST HIS BLOOD GLUCOSE AGAIN. AT 8:30 AM, THE PT TESTED ON ANOTHER METER AT "75 MG/DL". THE PT INDICATED THAT HIS BLOOD GLUCOSE READING MUST HAVE BEEN AROUND "70 MG/DL" AT 6AM THAT DAY. THE PT ALSO INDICATED THAT IF HE HAD KNOWN BETTER, HE WOULD HAVE HAD TWO GLUCOSE TABLETS AND A GLASS OF ORANGE JUICE BEFORE HE WENT OUT TO EAT BREAKFAST THAT DAY. THE PT'S TESTING FREQUENCY AND DIABETES MEDICATION REGIMEN HAS NOT RECENTLY CHANGED. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE UNIT OF MEASUREMENT WAS CORRECTLY SET TO MG/DL, THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURED AREA WAS NOT CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT HE PASSED OUT AFTER BASING HIS DIABETES TREATMENT ON AN ALLEGED INACCURATE HIGH LFS METER READING. 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 2781653

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R