BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1971210 · Received January 26, 2011

    Report

    Report Number
    2954323-2011-01113
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 17, 2010
    Report Date
    July 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2011. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN THE METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE METER IS DESIGNED TO REPORT READINGS OF 20 MG/DL TO 500 MG/DL. IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS LESS THAN 20 MG/DL. A READING LESS THAN 20 MG/DL WOULD DISPLAY A "LO" MESSAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2010 THEY GOT MESSAGE "LO", LOWER THAN FEELS READINGS OF 38 MG/DL AND 57 MG/DL ON THEIR PRECISION XTRA METER AND EXPERIENCED VERTIGO, HALLUCINATIONS, DIAPHORESIS AND TREMULOUSNESS WITH SUBSEQUENT LOSS OF CONSCIOUSNESS. THE CUSTOMER REPORTEDLY SELF-PRESENTED AT A HEALTH CARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN. THE CUSTOMER FURTHER REPORTED BEING DIAGNOSED WITH HYPERCHOLESTEROLEMIA, HYPERTENSION, UNSPECIFIED CARDIAC AND THYROID CONDITION. THE CUSTOMER REPORTEDLY SELF-TREATED WITH DIABETIC MEDICATIONS LANTUS AND GLIPIZIDE ER IN ADDITION TO ANTIHYPERTENSIVE, PSYCHOTROPIC, HYPERCHOLESTEROLEMIC, ANTIHYPOTHYROID AND ANTIGLAUCOMA MEDICATIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R