BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE RGT (CR-S) KIT

    MDR report key: 2990566 · Received March 5, 2013

    Report

    Report Number
    2050010-2013-00001
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGX
    PMA / PMN Number
    K071283
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE DETERMINED THE EVENT WAS ASSOCIATED WITH THE CR-S REAGENT CARTRIDGE. THE CR-S REAGENT CARTRIDGE HAD BEEN ON BOARD OF THIS INSTRUMENT FOR DAYS WITH APPROXIMATELY 60 TESTS VOLUME LEFT. THE CARTRIDGE WAS REPLACED, AND THE CALIBRATION AND QC PERFORMED USING THE NEW CR-S REAGENT CARTRIDGE PASSED. THE CUSTOMER WAS QUESTIONING WHETHER THE CR-S REAGENT WAS FROZEN AND THEN THAWED. CUSTOMER WAS MADE AWARE THAT THE FROZEN REAGENT CAN HAVE ON-BOARD STABILITY PROBLEMS. THE CUSTOMER INDICATED THEIR OUTSIDE LOCAL TEMPERATURE HAS BEEN AT ZERO DEGREES OR COLDER FOR WEEKS. PER THE CUSTOMER, THE PRODUCT WAS TRANSFERRED TO THE LABORATORY AS SOON AS IT WAS RECEIVED AND DID NOT SIT OUT ON THE RECEIVING DOCK. AT PRESENT, THERE HAS BEEN NO EVIDENCE TO SUGGEST THE REAGENT ARRIVED FROZEN OR PARTIALLY FROZEN. FAILURE MODE APPEARS TO BE RELATED TO THE ONE CR-S REAGENT CARTRIDGE. REPLACEMENT OF THE REAGENT CARTRIDGE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) CALLED IN TO REPORT WHILE PERFORMING A PREVENTIVE MAINTENANCE (PM) ON THE DXC 600 PRO ANALYZER AT THE CUSTOMER SITE, THE CUSTOMER INDICATED THEY HAD NUMEROUS ERRONEOUSLY LOW CREATININE CARTRIDGE (CR-S) RESULTS GENERATED AND REPORTED OUTSIDE OF THE LABORATORY. PHYSICIANS CALLED BACK THE LABORATORY AND QUESTIONED THE CR-S RESULTS SINCE THEY WERE ALL LOW. THE CUSTOMER INDICATED THAT THE PATIENT SAMPLES WERE RETESTED AND 3 PATIENT RESULTS WERE AMENDED SINCE THE DIFFERENCES BETWEEN THE ORIGINAL AND RERUN RESULTS WERE OUTSIDE OF THE 2SD TOTAL PRECISION CLAIM OF 0.6 MG/DL. BEC INVESTIGATOR CONTACTED THE CUSTOMER ON (B)(4) 2013, AND THE CUSTOMER INDICATED THEY WERE ONLY RUNNING QC ONCE A DAY. THE CUSTOMER STATED THAT QC WAS RUN AT NIGHT, HOURS BEFORE THE EVENT THE NEXT MORNING. WHEN QC WAS RUN AFTER THE PHYSICIANS QUESTIONED THE RESULTS, THE QC FAILED. PATIENT DEMOGRAPHICS AND RESULTS, PROVIDED BY THE CUSTOMER, ARE SUPPLIED IN THE FILE ATTACHMENT. NO EFFECT TO PATIENT TREATMENT HAS BEEN REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93771 CREATININE RGT (CR-S) KIT ALKALINE PICRATE, COLORIMETRY, CREATININE CGX BECKMAN COULTER NA M209195

    Patients

    Seq Age Sex Outcome Treatment
    1