BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 747389 · Received August 10, 2006

    Report

    Report Number
    2939301-2006-01092
    Event Type
    Injury
    Date Received
    August 10, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 2, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    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 2006, THE LAY PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) LISTENED TO THE RECORDED CALL WITH THE CUSTOMER CARE ADVOCATE (CCA) TO OBTAIN ADDITIONAL INFO. THE PT USES AN INSULIN PUMP. THE PT WAS ON VACATION WHEN HE OBTAINED HIGHER THAN USUAL READINGS ON THE REPORTED METER IN THE AM. THE SPECIFIC AM READINGS WERE NOT PROVIDED. HE THOUGHT HIS GLUCOSE LEVEL CHANGE WAS DUE TO HIS CHANGED MEALS ON VACATION. THAT NIGHT, AFTER DINNER, HE OBTAINED TWO BACK TO BACK READINGS > 500 MG/DL ON THE REPORTED METER. HE ADMINISTERED AN INSULIN BOLUS VIA HIS INSULIN PUMP BASED ON THE ELEVATED METER READINGS. AT 2.00 AM, THE PT'S WIFE CALLED EMS BECAUSE THE PT HAD PASSED OUT. BEFORE THE EMT'S ARRIVED, THE WIFE TESTED THE PT'S BLOOD GLUCOSE LEVEL AND OBTAINED A RESULT OF 313 MG/DL ON THE REPORTED METER. EMT'S ARRIVED AND OBTAINED A RESULT OF 11 MG/DL ON THE EMS METER WITHIN A FEW MINS OF THE RESULT OBTAINED ON THE LFS METER. THE PT WAS TREATED WITH TWO AMPS OF D50 IV AND TAKEN BY AMBULANCE TO THE ER. A RESULT OF 47 MG/DL WAS OBTAINED ON THE ER DEVICE. THE PT WAS TREATED WITH IV GLUCOSE AND GIVEN FOOD TO EAT IN THE ER. WHILE IN THE ER, A CONTROL SOLUTION TEST WAS PERFORMED ON THE LFS METER, THE RESULT OF "260 SOMETHING" WAS OUTSIDE OF THE SPECIFIED CONTROL SOLUTION RANGE (102-130 MG/DL). THE PT TOLD THE CCA HE HAD NO MORE OF THE TEST STRIPS USED AT THE TIME OF CONCERN. HOWEVER, HE HAD THE TEST STRIP LOT NUMBER AND REPORTED IT TO THE CCA. THE METER AND CONTROLS SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE LFS PRODUCT READ INACCURATELY WITH CONTROL SOLUTION. THE PT TOOK INSULIN BASED ON ELEVATED BLOOD GLUCOSE READINGS OBTAINED ON THE LFS PRODUCT AND THEN WAS FOUND HYPOGLYCEMIC AFTER PASSING OUT. THE PT RECEIVED EMERGENCY MEDICAL TREATMENT WITH IV GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2636234

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R