BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 18984391 · Received March 26, 2024

    Report

    Report Number
    3005621222-2024-00004
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 26, 2024
    Manufacturer
    I-SENS
    Product Code
    NBW
    UDI-DI
    00015482530501
    PMA / PMN Number
    K151164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO ANALYZE THE CAUSE OF THE LOW READINGS, I-SENS CONDUCTED CONTROL SOLUTIONS AND BLOOD TESTS USING THE RETURNED METERS AND RETURNED STRIPS. THE CONTROL SOLUTION TEST RESULTS WERE 133, 140, 139 MG/DL (A: 108~161 MG/DL) AND 240, 241, 249 MG/DL (B: 192~288 MG/DL), WHICH ALL MET THE ACCEPTABLE RANGE. AND WHEN TESTED WITH PREPARED BLOOD WITH A CONCENTRATION SIMILAR TO THE CONCENTRATION ESTIMATED TO BE THE PATIENT'S GLUCOSE LEVEL AT THE TIME OF THE INCIDENT, HI OCCURRED IN ALL CASES. THEREFORE, THE PRODUCT HAS BEEN CONFIRMED TO OPERATE NORMALLY. THE FOLLOWING IS A PARTIAL EXCERPT FROM THE ASSURE PRISM MULTI USER MANUAL, REGARDING ITS LIMITATIONS: "INACCURATE RESULTS MAY OCCUR IN SEVERELY HYPOTENSIVE (HAVING LOW BLOOD PRESSURE) INDIVIDUALS OR PATIENTS IN SHOCK. INACCURATE LOW RESULTS MAY OCCUR FOR INDIVIDUALS EXPERIENCING A HYPERGLYCEMIC HYPEROSMOLAR STATE, WITH OR WITHOUT KETOSIS. CRITICALLY ILL PATIENTS SHOULD NOT BE TESTED WITH THE ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM." BASED ON THE REPORTED CUSTOMER'S BLOOD GLUCOSE LEVEL, IT IS INFERRED THAT THE CUSTOMER MAY BE EXPERIENCING A HYPERGLYCEMIC HYPEROSMOLAR STATE. IN SUCH CASES, ASSURE PRISM MAY PRODUCE INACCURATE MEASUREMENT VALUES AS STATED IN THE USER MANUAL.

    Description of Event or Problem · 0

    CUSTOMER HAD SENT AN EMAIL STATING THAT THE GLUCOSE MONITORS ARE READING SEVERAL POINTS OFF FROM THE HOSPITAL READINGS. WHEN THIS BEGINS TO HAPPEN (AFTER ABOUT SIX MONTHS OF USE) WE END UP REPLACING THEM. AS RECENTLY AS LAST WEEK, WE HAD A READING OF 300, OUR LOCAL FIRE DEPARTMENT HAD A READING OF 500, AND THE HOSPITAL OBTAINED A READING OF 1100. THIS WAS A CRITICAL PATIENT IN DIABETIC KETOACIDOSIS WHO REQUIRED INTUBATION. ARKRAY FOLLOWED UP WITH CUSTOMER BY PHONE. VERIFIED THE READINGS WERE WITHIN 20 MINUTES OF EACH OTHER. CUSTOMER STORES METER AND TEST STRIPS TOGETHER IN THE AMBULANCE IN A MEDICAL BAG IN THE BACK OF THE AMBULANCE. METERS ARE STORED IN A TEMPERATURE-CONTROLLED ENVIRONMENT OF 68-72 DEGREES. CUSTOMER SAID THAT THE INCIDENT OCCURRED ON (B)(6) 2024 AT ABOUT 10:33 PM. THEY RECEIVED A CALL THAT A PATIENT WAS UNRESPONSIVE. EMS ARRIVED AT THE PATIENT'S HOME, TOOK HER GLUCOSE READING AND GAVE HER OXYGEN. PATIENT TAKES NOVOLOG AND VICTOZA FOR TYPE 2 DIABETES. SHE DOESN'T USE OXYGEN NORMALLY BUT WAS GIVEN OXYGEN UPON ARRIVAL AT HER HOME. VERIFIED THAT CUSTOMER SEALS THE TEST STRIP BOTTLE IMMEDIATELY AFTER REMOVING A STRIP. VERIFIED THEY USED ALCOHOL TO CLEAN THE PATIENT'S FINGERS, USED A NEW STERILE LANCET, AND THEY WIPED AWAY THE FIRST DROP THEN USED THE SECOND DROP OF BLOOD TO TEST. THEY USED A FRESH SAMPLE OF CAPILLARY BLOOD FROM THE FINGERTIP. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS HYPOTENSIVE AND WAS GIVEN EPINEPHRINE. THE PATIENT IS STILL ALIVE. REPLACED METER, STRIPS AND SENT RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488172 ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW I-SENS GM505RA WL27MAM7B 00015482530501

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| L| H