BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA2

    MDR report key: 14072912 · Received April 11, 2022

    Report

    Report Number
    1823260-2022-00991
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 29, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REMOVED THE CALCIUM REAGENT PACK AND STATED THERE MAY HAVE BEEN SOME CRYSTALLIZATION AROUND THE TOP OF THE PACK. THE CUSTOMER CALIBRATED AND RAN CONTROLS AND STATED THE ISSUE WAS RESOLVED. THE FIELD SERVICE ENGINEER COULD NOT FIND A HARDWARE ISSUE. PRECISION STUDIES WERE PERFORMED AND THE CUSTOMER RAN CONTROLS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED THE ISSUE WAS RELATED TO THEIR LABORATORY WATER SUPPLY. THE CUSTOMER'S WATER SYSTEM UNDERWENT MAINTENANCE ACTIVITIES PRIOR TO GENERATING THE COMPLAINED RESULTS. THE ISSUE WITH THE WATER SUPPLY WAS RESOLVED. WATER REQUIREMENTS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH INCORRECT HANDLING OF THE DEVICE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THAT THE LABORATORY HAD SERVICE PERFORMED ON THEIR WATER SAMPLER SYSTEM ON THE NIGHT OF 16-MAR-2022. THE REPORTER STATED THAT THEY THEN STARTED HAVING ISSUES WITH QUALITY CONTROL RECOVERY WITH CA2 CALCIUM GEN.2 ON THE COBAS 6000 C (501) MODULE AFTER PERFORMING DAILY MAINTENANCE ON (B)(6) 2022. CONTROLS WERE OUTSIDE OF RANGE HIGH AND WHEN REPEATED, THEY WERE STILL HIGH. CONTROLS LATER RECOVERED WITHIN RANGE, SO THE CUSTOMER STARTED TESTING PATIENT SAMPLES. EIGHT PATIENT SAMPLES HAD DISCREPANT CALCIUM RESULTS. THE INITIAL RESULTS FOR THE FIRST SEVEN SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT FOR THE EIGHTH SAMPLE WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON A SECOND ANALYZER AND THE REPEAT VALUES WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.6 MG/DL AND REPEATED AS 10.0 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 7.0 MG/DL AND REPEATED AS 9.1 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 7.0 MG/DL AND REPEATED AS 9.9MG/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 7.3 MG/DL AND REPEATED AS 9.3 MG/DL. THE FIFTH SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 7.1 MG/DL AND REPEATED AS 9.3 MG/DL. THE SIXTH SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 5.6 MG/DL AND REPEATED AS 9.6 MG/DL. THE SEVENTH SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 7.0 MG/DL AND REPEATED AS 9.9 MG/DL. THE EIGHTH SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 4.9 MG/DL AND REPEATED AS 9.1 MG/DL. THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878882 CA2 TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM CHW ROCHE DIAGNOSTICS CA G2 ASKU 04015630924035

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male