BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE PRISM MULTI BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 17359001 · Received July 20, 2023

    Report

    Report Number
    3005621222-2023-00012
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 12, 2023
    Manufacturer
    I-SENS
    Product Code
    NBW
    UDI-DI
    00015482530501
    PMA / PMN Number
    K151164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE COMPLAINT METER WAS RETURNED, I-SENS CONDUCTED CONTROL SOLUTION TESTS WITH THE RETURNED METER AND COMPLAINT LOT RETAINED STRIPS. ALL RESULTS WERE WITHIN THE ALLOWABLE RANGE WIRH 153, 160, 156, 159, 160 MG/DL (A: 112-167 MG/DL), AND 235, 252, 239, 231, 250 (B: 189-283 MG/DL). ADDITIONALLY, AS A RESULT OF DISASSEMBLING THE METER, THERE WERE NO ABNORMALITIES SUCH AS INFLOW OF BLOOD OR FOREIGN SUBSTANCE OR PIN DEFORMATIONS FOUND WITHIN THE CONNECTORS, THEREFORE, IT IS DETERMINED THAT THE METER IS FUNCTIONING NORMALLY.

    Description of Event or Problem · 0

    ON (B)(6), 2023, FRANKLIN COMMUNITY FIRE DEPARTMENT RECEIVED A CALL FOR CHEST PAINS. UPON ARRIVAL, PATIENT WAS CONSCIOUS, AND SHE WAS EXHIBITING SIGNS OF LOW BLOOD GLUCOSE. THE FIRE DEPARTMENT DID A BLOOD GLUCOSE TEST WITH THE ASSURE PRISM METER AND RECEIVED A READING OF 31. FIRE DEPARTMENT PERSONNEL HAD HER EAT A PEANUT BUTTER AND JELLY SANDWICH AND DRINK SOME SWEET TEA. THEY CHECKED HER BLOOD GLUCOSE AGAIN 10 MINUTES LATER WITH THE ASSURE PRISM METER AND THE READING WAS 32, WHICH SEEMED UNUSUAL. THE EMS CREW ARRIVED TO TAKE OVER THE SITUATION, AND WHEN THEY TESTED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER, THE READING WAS 480. THE FIRE DEPARTMENT LEFT, AND EMS PERSONNEL TRANSPORTED PATIENT TO THE HOSPITAL WHERE IT IS UNKNOWN WHAT KIND OF TREATMENT SHE RECEIVED. WHEN CALLER RETURNED TO THE FIRE DEPARTMENT AFTER THE CALL, THE CALLER PERFORMED A BLOOD GLUCOSE TEST ON HIMSELF WITH THE ASSURE PRISM AND RECEIVED A READING OF 41. CALLER PERFORMED A CONTROL SOLUTION TEST WITH THE ASSURE PRISM USING L2 CONTROL SOLUTION AND RECEIVED A READING OF 31 AND THE RANGE FOR THE L2 CONTROL SOLUTION WAS 31, INDICATING THE METER WAS STILL READING LOW, EVEN WITH CONTROL SOLUTION. THE SAME CONTROL SOLUTION WAS USED TO TEST OTHER ASSURE PRISM METERS THAT THE CALLER HAD, AND THOSE TEST RESULTS WERE WITHIN RANGE. REPLACED METER, STRIPS AND SENT RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765185 ASSURE PRISM MULTI BLOOD GLUCOSE TEST SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW I-SENS GM505RA UL06MAD3A 00015482530501

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H