BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2

    MDR report key: 12983486 · Received December 13, 2021

    Report

    Report Number
    1823260-2021-03666
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 18, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHW
    UDI-DI
    04015630924035
    PMA / PMN Number
    K113521
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ON 21-DEC-2021, THE FIELD SERVICE ENGINEER (FSE) PERFORMED A HARDWARE CHECK BY TEST PERFORMANCE AND A CALCIUM PRECISION TEST WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. UPON INVESTIGATION OF SUBMITTED DATA, A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE THE PROVIDED CALIBRATION DATA WERE WITHIN SPECIFICATIONS. THE QC FOR LEVEL 2 WAS WITHIN RANGE. THE REACTION MONITORS FOR INITIAL AND ALL OF THE RERUNS DID NOT INDICATE AN ISSUE. THE ALARM TRACE REVEALED SEVERAL CALIBRATION ERRORS AND SENSITIVITY ERRORS ON THE DAY OF THE EVENT. THERE WERE ALSO ABNORMAL PROBE SUCKING AND SAMPLE SHORT ALARMS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 C (501) MODULE WITH (B)(4). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS DEEMED IMPLAUSIBLE BY THE REPORTER WHICH PROMPTED A RERUN OF THE TEST. THE INITIAL AND THE FIRST REPEAT RESULTS WERE FROM AN OLD REAGENT LOT. THE REPEAT RESULT REMAINED HIGH, PROMPTING THE REPORTER TO CHANGE THE REAGENT WITH A NEW LOT NUMBER AND RERUN THE SAMPLE. THE REPEAT RESULT WAS DEEMED CORRECT. SAMPLE (B)(6) HAD AN INITIAL CALCIUM RESULT OF 14.7 MG/DL AT 2:44 PM. THE FIRST REPEAT RESULT USING THE REAGENT WITH THE OLD LOT NUMBER WAS 14.7 MG/DL AT 4:39 PM. THE SECOND REPEAT RESULT USING THE REAGENT WITH THE NEW LOT NUMBER WAS 9.4 MG/DL AT 5:47 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887045 CA2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS CA G2 56269001 04015630924035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown