BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 823976 · Received February 22, 2007

    Report

    Report Number
    2939301-2007-00156
    Event Type
    Injury
    Date Received
    February 22, 2007
    Report Date
    February 7, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2007, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRASMART METER WAS REVERTING TO THE SETUP MODE. IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUE STARTED, HOW LONG THE PT WAS UNABLE TO TEST HIS BLOOD GLUCOSE WITH THE REPORTED METER, AND WHAT HIS TESTING FREQUENCY WAS. THE PT HAD SYMPTOMS OF "SLIGHT DIZZINESS" AND HIS "LEGS WERE JERKING." THE PT ALSO STATED THAT HE "KIND OF BLACKED OUT." THE PT WALKED TO A FIRE DEPARTMENT THAT WAS TWO BLOCKS AWAY FOR ASSISTANCE. WHEN HE GOT THERE, THE FIRE DEPARTMENT TESTED THE PT'S BLOOD GLUCOSE USING AN UNIDENTIFIED DEVICE. THE FIRE DEPARTMENT DID NOT TELL THE PT WHAT RESULT WAS OBTAINED BUT THEY MENTIONED THAT HIS BLOOD GLUCOSE WAS "JUST REALLY LOW." THE PT WAS TREATED WITH ORAL GLUCOSE MIXED WITH SODA. HE WAS ALSO GIVEN "SUGAR PILLS." HE STAYED AT THE FIRE DEPARTMENT FOR ABOUT 30 MINUTES. WHEN THE PT GOT HOME ABOUT AN HOUR LATER, HE TOOK HIS PILLS FOR EPILEPSY, "VERAPAMIL" FOR ATRIAL FIBRILLATION, AND 3 "GNC MULTIVITAMIN" CAPSULES WITH "SUGAR ADDITIVES." THE ALLEGED METER ISSUE WAS NOT RESOLVED. THE METER WAS REPLACED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: IF THE PT WAS ABLE TO TEST WITH A BACKUP METER, WHEN THE SYMPTOMS STARTED, WHAT HIS MEDICATION REGIMEN WAS BEFORE THE METER ISSUE STARTED, AND IF THE PT MADE ANY CHANGES TO THE REGIMEN DURING THE TIME OF CONCERN. IN PARTICULAR, IT WOULD BE HELPFUL TO VERIFY WHETHER OR NOT THE SYMPTOMS BEGAN AFTER THE ALLEGED METER ISSUE. IT WOULD ALSO HAVE BEEN HELPFUL TO KNOW IF THE PT ATTEMPTED TO TREAT HIMSELF AFTER DEVELOPING THE SYMPTOMS AND IF THE PT ACTUALLY LOST CONSCIOUSNESS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING INFO: THE PT ALLEGES HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE FOR AN UNKNOWN PERIOD OF TIME, DEVELOPED SYMPTOMS SUGGESTIVE OF LOW BLOOD GLUCOSE, AND REC'D MEDICAL TREATMENT FOR HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2631853

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening| R