BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243792 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03206
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PROD(S) FOR EVAL. IF THE PROD(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PROD(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LFS ALLEGING A BATTERY INDICATOR ON HIS LFS METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT F/U QUESTIONS AND OBTAINED THE FOLLOWING INFO: THE PT MENTIONED THAT HE NORMALLY TESTS HIS BLOOD GLUCOSE TWICE A DAY; HOWEVER, DUE TO THE BATTERY INDICATOR HE HAS NOT TESTED HIS BLOOD GLUCOSE FOR ABOUT A MONTH. THE PT CONTINUED TO TAKE HIS DIABETES MEDICATION ON A REGULAR BASIS. IN 2008, THE PT REPORTEDLY STARTED TO FEEL UNWELL, VOMITING, NOT BEING ABLE TO KEEP HIS FOOD DOWN. THE PT DID NOT SEEK ANY MEDICAL ATTN OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. TWO DAYS LATER, THE PT HAD NOT EATEN BREAKFAST AND DECREASED HIS INSULIN IN THE MORNING TO 15 UNITS INSTEAD OF 25 UNITS DUE TO FEELING UNWELL. THE PT DECREASED IT BASED ON HIS PHYSICIAN'S RECOMMENDATION. BY 3 PM THAT DAY THE PT WAS NOT SPEAKING PROPERLY AND WAS "NOT WITH IT", THEREFORE, HIS WIFE CONTACTED THE PARAMEDICS WHO ARRIVED 10 MINS LATER. THE PT DOES NOT RECALL HIS INITIAL READING ON THE PARAMEDICS METER. THE PARAMEDICS PUT THE PT ON A DRIP AND TOOK HIM TO THE HOSP. THE PT CLAIMS THE DRIP WAS CLEAR FLUIDS AND GLUCOSE. AT THE HOSP, THE PT'S BLOOD GLUCOSE WAS TESTED AND HIS READING WAS 32.1 MMOL/L ON AN UNK METER. WHILE IN THE HOSP, THE PT WAS KEPT ON THE DRIP AND WAS TESTED WITH INSULIN. THE PT CLAIMS THAT THE DIAGNOSIS IN THE HOSP WAS HYPOGLYCEMIA. PT WAS DISCHARGED FIVE DAYS LATER AROUND 5:00 PM. PRIOR TO BEING RELEASED FROM THE HOSP, THE PT'S BLOOD GLUCOSE WAS 12.4 MMOL/L AT 10:00 AM. THE PT HAS HAD THE METER FOR TWO YRS AND DID NOT KNOW THAT HE COULD REPLACE THE BATTERY ON HIS OWN. METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PT CLAIMED HE WAS UNABLE TO TEST FOR A MONTH AND WAS LATER TREATED BY HEALTHCARE PROFESSIONALS FOR HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2735485

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R