BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 15419098 · Received September 14, 2022

    Report

    Report Number
    1823260-2022-02833
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336158876
    PMA / PMN Number
    K191899
    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 CALIBRATION PERFORMED ON (B)(6) 2022 WAS WITHIN THE SPECIFIED RANGES. THE CUSTOMER DID NOT PROVIDE THE ACTUAL QC RESULTS WITH TIMESTAMPS AND ONLY PROVIDED QC CHARTS. FOR THE DATES OF (B)(6) 2022, LEVEL 1 QC OF SODIUM AND CHLORIDE SHOWED RESULTS THAT WERE WITHIN 2 SD AND THEN A SUBSEQUENT RESULT THAT WAS OUT OF RANGE. THE LEVEL 2 QC OF SODIUM AND CHLORIDE WAS WITHIN THE SPECIFIED RANGES. THE INVESTIGATION WAS UNABLE TO DETERMINE IF THE LEVEL 1 QC WAS ACCEPTABLE PRIOR TO RUNNING THE PATIENT SAMPLE. HOWEVER, THE CUSTOMER STATED THAT THE QC RECOVERY WAS ACCEPTABLE PRIOR TO THE EVENT. THE ALARM TRACE SHOWED "SAMPLE PROBE: ABNORMAL ASPIRATION ERROR", "SAMPLE FOAM DETECTION", "SAMPLE CLOT DETECTION" AND "ABNORMAL ASPIRATION SAMPLE PIPETTER S1" ERRORS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER (FSE) TIGHTENED THE THUMB SCREW. HE ALSO FLUSHED THE SAMPLE PROBE, SIPPER NOZZLE, AND VACUUM NOZZLES. HE CLEANED THE ELECTRODE BLOCK AND CHECKED THE SAMPLE PROBE ADJUSTMENTS. THE CUSTOMER PERFORMED QC AND PRECISION TESTS WITH ACCEPTABLE 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 · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA AND CI FOR GEN.2 RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN ON THEIR OTHER COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL SODIUM RESULT FROM THE ANALYZER WAS 159 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 141 MMOL/L. THE INITIAL CHLORIDE RESULT FROM THE ANALYZER WAS 119 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 103 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE SODIUM ELECTRODE LOT NUMBER, CHLORIDE ELECTRODE LOT NUMBER, AND THEIR EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622526 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA 07613336158876

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female