BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE 4 BLOOD GLUCOSE SYSTEM

    MDR report key: 3140559 · Received May 31, 2013

    Report

    Report Number
    1832816-2013-00042
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 15, 2013
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    PMA / PMN Number
    K070088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER REPORTED TO BE INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS DAMAGED; CASING CRACKED, SCREWS MISSING, LCD COVER LOOSE AND METER DID NOT REGISTER THE TEST STRIP THEREFORE, THE METER COULD NOT BE EVALUATED FOR PERFORMANCE. ALSO, THE RETURNED METER MEMORY DID NOT CONTAIN THE REPORTED RESULTS. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 METER WAS READING HIGH. THE CALLER STATED THEY TREATED A PATIENT WITH INSULIN BASED ON INACCURATELY HIGH READINGS ON THE ASSURE 4 METER, WHICH CAUSED HYPOGLYCEMIA AND THE PATIENT WAS SENT TO THE ER. HE STATED HE KNEW THE METER WAS RUNNING HIGH BECAUSE THE LAB RESULTS THAT HE RECEIVED WERE LOWER THAN THE METER. ON (B)(6) 2013, THE NURSE TOOK THE PATIENT¿S BLOOD GLUCOSE READING AND RECEIVED A 512MG AT 4:30P. SHE WAS TREATED WITH INSULIN AND THE DOCTOR WAS CALLED BECAUSE THEY ARE REQUIRED TO CONTACT THE DOCTOR ANYTIME A BLOOD SUGAR IS OVER 500MG. AT 5PM, HER BLOOD GLUCOSE WAS 141 AND INSULIN WAS GIVEN BASED ON A SLIDING SCALE. AT ABOUT 8PM, THE PATIENT WAS AWAKE, BUT WAS SLOW TO RESPOND. THEY TOOK HER BLOOD GLUCOSE READING AGAIN AND IT WAS 41MG. THEY TREATED THE PATIENT WITH GLUCAGON AND SHE STARTED HAVING SEIZURE LIKE ACTIVITIES. AT THAT TIME THE NURSE CALLED 911 AND THE DOCTOR. THE NURSE DOCUMENTED HER VITALS AND THE PATIENT WAS TAKEN TO THE ER TO BE STABILIZED. CONTROLS USED WERE IN RANGE. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240807 ASSURE 4 BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 560001 SS060M

    Patients

    Seq Age Sex Outcome Treatment
    1 83 Hospitalization| L