BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2 CALCIUM GEN.2

    MDR report key: 12037338 · Received June 21, 2021

    Report

    Report Number
    1823260-2021-01783
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 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 · 1

    UNIQUE DEVICE IDENTIFIER (UDI) (B)(4). THE CUSTOMER'S CALIBRATION RESULTS ON 18-MAY-2021 WERE OK. THE CUSTOMER'S QC RESULTS PRIOR TO THE EVENT WERE ACCEPTABLE. THE CUSTOMER ATTEMPTED TO RECALIBRATE ON THE AFFECTED CALCIUM REAGENT PACK ON (B)(6) 2021, BUT RECEIVED A CALIBRATION ERROR AND QC RESULTS WERE OUT OF RANGE. THE CUSTOMER'S SYSTEM ALARM TRACE CONTAINED NO ABNORMALITIES. THE CUSTOMER'S SAMPLE PRE-ANALYTICAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER CONFIRMED THE FAILING CALIBRATION RESULTS. HE REMOVED THE AFFECTED CALCIUM REAGENT PACK. HE PERFORMED PRECISION, CALIBRATION, AND QC WITH THE STANDBY CALCIUM REAGENT PACK AND RECOVERED PASSING RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 21 PATIENTS TESTED ON A COBAS 8000 C 502 MODULE SERIAL NUMBER (B)(4). PRIOR TO PATIENT TESTING, THE CUSTOMER CONFIRMED THE CALCIUM QC WAS ACCEPTABLE. THE INITIAL CALCIUM RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLES DUE TO MULTIPLE HIGH CRITICAL CALCIUM RESULTS AND THE HEALTHCARE PROVIDERS REQUESTED REPEAT CALCIUM ORDERS. THE CUSTOMER PROVIDED THE CRITICAL VALUE CUTOFF OF 14 MG/DL. FOR REPEAT TESTING, THE CUSTOMER TESTED THE SAMPLES ON THE SAME ANALYZER BUT USED THE STANDBY CALCIUM REAGENT PACK. FROM THE 21 QUESTIONABLE CALCIUM RESULTS, THE CUSTOMER CONFIRMED SIX OF THE CALCIUM RESULTS WERE "ORIGINALLY CRITICAL/URGENT VALUES THAT REPEATED NOT CRITICAL/URGENT," AND TWELVE OF THEM WERE "ORIGINALLY ABNORMAL AND RERAN IN THE NORMAL RANGE." THE SPECIFIC RESULTS FOR ALL 21 PATIENTS WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER PROVIDED QUESTIONABLE CALCIUM RESULTS FOR THREE PATIENTS: PATIENT (B)(6) INITIAL CALCIUM RESULT WAS 14.3 MG/DL, AND THE PATIENT'S REPEAT CALCIUM RESULT WAS 11.1 MG/DL. PATIENT (B)(6) INITIAL CALCIUM RESULT WAS 15.0 MG/DL, AND THE PATIENT'S REPEAT CALCIUM RESULT WAS 11.7 MG/DL. PATIENT (B)(6) INITIAL CALCIUM RESULT WAS 14.6 MG/DL, AND THE PATIENT'S REPEAT CALCIUM RESULT WAS 11.3 MG/DL. THE CUSTOMER CONFIRMED THE REPEAT CALCIUM RESULTS WERE DETERMINED CORRECT AND CORRECTED REPORTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933087 CA2 CALCIUM GEN.2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS CA G2 54990101

    Patients

    Seq Age Sex Outcome Treatment
    1