BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2091992 · Received May 18, 2011

    Report

    Report Number
    2939301-2011-04107
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    May 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THE PATIENT'S ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE PATIENT. THE REPORTER MENTIONED THAT ON AN UNSPECIFIED DATE AND TIME THE PATIENT TESTED THEIR BLOOD GLUCOSE AND OBTAINED ALLEGEDLY A HIGH READING. APPROXIMATELY 3 HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING PALE, WEAK, DIARRHEA, SWEATING, CLAMMY, STOPPED BREATHING, "DIAPHORETIC, AND PASSED OUT. THE REPORTER TREATED THE PATIENT WITH COKE TO ELEVATE THEIR BLOOD GLUCOSE AND CONTACTED THE PARAMEDICS. THE REPORTER DOES NOT RECALL THE READING ON THE PARAMEDIC'S METER OR WHAT THE PATIENT'S METER READING WAS AT THE TIME OF THE INCIDENT. THE PATIENT RAN OUT OF THE SUBJECT TEST STRIPS AND DID NOT HAVE ANY MORE TEST STRIPS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE EVENT, READINGS AT THE TIME OF THE EVENT, READINGS ON THE EMS'S METER AND WHAT EMT'S TREATED THE PATIENT WITH AND HOW SOON AFTER THE PATIENT REGAINED CONSCIOUSNESS. IT WOULD HAVE ALSO BEEN HELPFUL TO KNOW WHETHER THE PATIENT WAS TAKEN TO THE HOSPITAL AND WHETHER THE PATIENT'S DIABETES REGIMEN WAS CHANGED. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, THE PATIENT LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SEEK MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R