BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM GEN. 2

    MDR report key: 11762812 · Received May 3, 2021

    Report

    Report Number
    1823260-2021-01314
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 11, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    PMA / PMN Number
    K113521
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FIELD SERVICE ENGINEER WAS THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) # (B)(4). THE CUSTOMER STARTED A NEW REAGENT LOT OF CALCIUM ON (B)(6) 2021 AND HAD ISSUES PASSING CALIBRATION WITH THE NEW REAGENT LOT. THE CUSTOMER LOADED A NEW PACK OF REAGENTS THAT WAS ALSO FROM THE NEW LOT AND WAS ABLE TO PASS CALIBRATIONS. THE CUSTOMER STATES THAT QC AFTER CALIBRATION PASSED WAS WITHIN RANGE. THE FIELD SERVICE ENGINEER FOUND THAT THE REAGENT PACK HAD BUILD-UP ON THE TOP OF IT. THE PACK WAS REPLACED AND MONITORED WITHOUT FURTHER ISSUES. THE CUSTOMER RAN CALIBRATION AND QC TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE CALCIUM GEN. 2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 MODULE ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 6.28 MG/DL AND THE REPEAT RESULTS WERE 8.92 MG/DL AND 8.64 MG/DL. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. A NEW PATIENT SAMPLE WAS DRAWN AND THE RESULT WAS 9.0 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663788 CALCIUM GEN. 2 CALCIUM TEST SYSTEM CHW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR