BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 7014363 · Received November 9, 2017

    Report

    Report Number
    1823260-2017-02568
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 24, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    BAD CUVETTE QUALITY WAS SUSPECTED, BUT COULD NOT BE CONFIRMED DURING INVESTIGATIONS. AFTER EXCHANGE OF THE CUVETTES AND THE SAMPLE PROBE, NO FURTHER ISSUES WERE OBSERVED. THE ISSUE WAS BELIEVED TO BE RELATED TO SAMPLE QUALITY AS THERE WERE A NUMBER OF ABNORMAL SAMPLE ASPIRATION ALARMS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR FOUR PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON THE COBAS 6000 C (501) MODULE - C501. OF THE FOUR SAMPLES, TWO HAD ERRONEOUS RESULTS FOR CHOL2 CHOLESTEROL GEN.2 (CHOL) AND CREP2 CREATININE PLUS VER.2 (CREA). THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH A CHOL VALUE OF 7 MG/DL AND REPEATED AS 158 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED WITH A CREA VALUE OF 0.01 MG/DL AND REPEATED AS 1.10 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CHOL REAGENT LOT NUMBER WAS 236242, WITH AN EXPIRATION DATE OF JANUARY 2018. THE CREA REAGENT LOT NUMBER WAS 242159, WITH AN EXPIRATION DATE OF JANUARY 2018. THE QUESTIONED MEASUREMENTS COULD BE TRACED TO TWO SPECIFIC CUVETTES ON THE ANALYZER. REACTION MONITORS SHOWED THAT NO SAMPLE WAS PIPETTED INTO EACH CUVETTE. THE CUSTOMER LATER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR TWO ADDITIONAL SAMPLES. THE MEASUREMENTS WERE TRACED BACK TO A THIRD SPECIFIC CUVETTE. THE CUVETTE LOT NUMBER USED ON THE ANALYZER WAS 161102. THE ALARM TRACE DEMONSTRATED MANY ABNORMAL PROBE ASPIRATION ALARMS ON THE DAY OF THE EVENT. THIS STRONGLY INDICATES POOR SAMPLE QUALITY. IF CUSTOMER DOES NOT ACT IMMEDIATELY AS DESCRIBED IN PRODUCT LABELING FOR THIS ALARM, THERE IS A HIGH RISK FOR LOW RESULTS AS OBSERVED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793271 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1