BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE PRECISION NEO H

    MDR report key: 5678609 · Received May 25, 2016

    Report

    Report Number
    2954323-2016-02320
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    April 28, 2016
    Report Date
    September 9, 2016
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K153330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT'S WERE RETURNED AND INVESTIGATED. THE COMPLAINT IS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND TESTED WITH RETAINED TEST STRIPS. THE COMPLAINT IS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. FURTHER INVESTIGATION OF THE RETURNED METER HAS BEEN PERFORMED USING WHOLE BLOOD TESTING. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING BLOOD TESTING. IN ADDITION, THIS SERVES AS A CORRECTION FOR THE INITIAL REPORT, FOLLOW UP #1 AND FOLLOW-UP#2. CORRECT CATALOG # IS 71451-01 AND THE SECTION 510K # IS K153330.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. DATE RECEIVED BY MANUFACTURER WAS INCORRECTLY DOCUMENTED IN THE MDR 30 DAY FOLLOW UP #1 REPORT. THE CORRECT DATE IS JUNE 09, 2016.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ON AN UNSPECIFIED DATE/TIME A PATIENT WAS FEELING "VERY WEAK" AND THEN SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. A BLOOD GLUCOSE TEST WAS PERFORMED USING AN ADC BLOOD GLUCOSE METER AND A RESULT OF 118 MG/DL WAS OBTAINED. BECAUSE THE RESULT WAS INCONSISTENT WITH A LOSS OF CONSCIOUSNESS, A LABORATORY GLUCOSE TEST WAS DONE AND A RESULT OF 18 MG/DL WAS RECEIVED. THE PATIENT WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH A GLUCAGON INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332700 FREESTYLE PRECISION NEO H BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 4500166038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R