BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY ANALYZER

    MDR report key: 22520385 · Received July 16, 2025

    Report

    Report Number
    2122870-2025-00088
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 16, 2025
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    JJE
    UDI-DI
    15099590265380
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: SERVICE WAS DISPATCHED ON 30JUN2025. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THAT ONLY MONITOR AND COMPUTER WERE PLUGGED INTO IT. BASED ON FIRE DEPARTMENT RECOMMENDATIONS, FSE REPLACED THE CHARRED SURGE PROTECTOR (PART NUMBER PN 973059) BY AN ALTERNATE ONE. A COMPLAINT SEARCH WAS PERFORMED FOR INSTRUMENT SERIAL NUMBER (SN) (B)(6) WITHIN THE TIMEFRAME OF 14-DAYS PRIOR TO THE EVENT OCCURRED TO THE CURRENT DAY (16JUN2025 ¿ 11JUL2025) AND NO SIMILAR PREVIOUS/FURTHER COMPLAINTS WERE FOUND FOR THIS ISSUE. A GLOBAL COMPLAINT SEARCH WAS PERFORMED FOR PN 973059 WITHIN TIMEFRAME OF ONE YEAR (11JUL2024 ¿ CURRENT DAY 11JUL2025) AND NO SIMILAR COMPLAINTS WERE FOUND FOR THIS ISSUE. SYSTEM CHECK PASSED ON 30JUN2025. THE CUSTOMER IS OPERATIONAL AND DOES NOT REQUIRE FURTHER CONTACT. IN CONCLUSION, THERE IS SUFFICIENT EVIDENCE PROVIDED TO REASONABLY SUGGEST A HARDWARE MALFUNCTION WAS THE LIKELY CAUSE OF THIS EVENT. REPLACING SURGE PROTECTOR AS PART OF ROUTINE TROUBLESHOOTING RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE CUSTOMER REPORTED A CHARRED SURGE PROTECTOR (P/N 973059) CONNECTED TO UPS (UNINTERRUPTED POWER SUPPLY) ON ACCESS 2 INSTRUMENT SERIAL NUMBER (S/N) (B)(6).. THE EVENT OCCURRED IN THE AFTERNOON WHEN THE INSTRUMENT WAS RUNNING CUSTOMER¿S STANDARD TEST MENU. FLAMES WERE OBSERVED BY THE CUSTOMER. ACCORDING TO THEIR EMERGENCY PREPAREDNESS PLANNING (EPP) IN PLACE, THE STAFF WAS EVACUATED. FIRE EXTINGUISHER WAS USED AND FIRE DEPARTMENT WAS CALLED. THERE WAS NO REPORT OF EXPOSURE NOR ANY HARM TO PATIENTS, USERS OR OTHER PERSONS ATTRIBUTABLE TO ANY OUTPUT OF THIS DEVICE. NOR ERRONEOUS NEITHER DELAYED PATIENT SAMPLE RESULTS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WAS NO DELAY IN TREATMENT OR DIAGNOSIS REPORTED. SERVICE WAS DISPATCHED ON 30JUN2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554274 ACCESS 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC 15099590265380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown