BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 798504 · Received December 20, 2006

    Report

    Report Number
    2939301-2006-01693
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    December 10, 2006
    Report Date
    December 10, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON DECEMBER 10, 2006 THE LAY PATIENT'S GRANDSON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE PATIENT OBTAINED A RESULT OF 162 MG/DL ON THE REPORTED METER IN THE EVENING. SHE ATE DINNER AND HER FAMILY GAVE HER ADDITIONAL DIABETES MEDICATION BASED ON THE METER READINGS PER HER USUAL REGIMEN. THE DIABETES MEDICATION NAME AND DOSE WERE NOT PROVIDED. THE PATIENT WENT TO BED. IN THE MORNING, THE PATIENT LATER TOLD HER GRANDSON SHE HAD FELT SOMETHING WAS WRONG, BUT SHE WAS UNABLE TO REACH FOR THE TELEPHONE OR TO GET CANDY AT HER BESIDE. SHE DID NOT RESPOND TO HER FAMILY'S PHONE CALL. THE FAMILY WENT TO SEE HER AND FOUND HER UNCONSCIOUS. THE FAMILY CALLED EMS. ON ARRIVAL, EMT'S OBTAINED A RESULT OF "LESS THAN 15" ON THE EMS METER COMPARED TO A RESULT OF 62 MG/DL ON THE REPORTED METER. EMT'S GAVE THE PATIENT A GLUCAGON INJECTION. AFTER 10 MINUTES, THE PATIENT REGAINED CONSCIOUSNESS. AT THAT TIME THE EMT'S OBTAINED A RESULT OF 95 MG/DL ON THE EMS METER COMPARED TO A RESULT OF 182 MG/DL ON THE REPORTED METER. BASED ON STATISTICAL METHODOLOGY, BOTH CALCULATED DIFFERENCES BETWEEN THE REPORTED METER AND EMS METER READINGS EXCEED THE EXPECTED VALUE OF <=30% AND/OR <=30 MG/DL. AFTER RECEIVING GLUCAGON, THE PATIENT ATE FOOD. THE FAMILY IMMEDIATELY PURCHASED A NEW METER AS ADVISED BY THE EMT'S. THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO WALK THE GRANDSON THROUGH A CONTROL SOLUTION TEST BECAUSE THE CONTROL SOLUTION WAS EXPIRED. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE LFS PRODUCT READ HIGH COMPARED TO THE EMS METER. THE PATIENT WAS GIVEN MEDICATION ALLEGEDLY BASED ON THE REPORTED METER READING. SHE EXPERIENCED LOSS OF CONSCIOUSNESS. EMT'S OBTAINED A HYPOGLYCEMIC READING ON THE EMS METER AND TREATED THE PATIENT WITH GLUCAGON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2658244

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R