BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS P 612 PRE-ANALYTICAL SYSTEM

    MDR report key: 14014782 · Received April 5, 2022

    Report

    Report Number
    1823260-2022-00957
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 10, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STOPPED THE ANALYZER AND MANUALLY WASHED THE SAMPLE PROBE. THE CUSTOMER DISCOVERED THE SAMPLE PROBE HAD A PIECE OF GEL ON THE SURFACE. THE INVESTIGATION REVIEWED THE SYSTEM'S ALARM TRACE AND FOUND ASPIRATION ALARMS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THE CUSTOMER'S COBAS P 612 PRE-ANALYTICAL SYSTEM HAD THE MINIMUM VOLUME SET TO 100 UL AND THE PATIENT'S SAMPLE TUBE WAS SENT FROM THE P 612 PRE-ANALYTICAL SYSTEM TO THE COBAS PRO C 503. THE INVESTIGATION FOUND THE PATIENT'S SAMPLE TUBE CAUSED A CLOT AND ABNORMAL ASPIRATION ALARMS IN PARALLEL. THE MINIMUM VOLUME SETTINGS IN THE COBAS P 612 PRE-ANALYTICAL SYSTEM WERE RECONFIGURED FROM 100 UL TO 400 UL. THE INVESTIGATION FOUND THE COBAS P 612 PRE-ANALYTICAL SYSTEM PERFORMED AS CONFIGURED. IT WAS CONFIRMED THE P 612 PRE-ANALYTICAL SYSTEM AND THE COBAS PRO C 503 ARE RUNNING WITHOUT ANY ISSUES AND RECONFIGURATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2, ALB2 ALBUMIN GEN.2, GLUC3 GLUCOSE HK GEN.3, AND TP2 TOTAL PROTEIN GEN.2 RESULTS FOR FIVE PATIENTS TESTED ON A COBAS C 503 ANALYTICAL UNIT. THE PATIENT'S INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLES. SAMPLE 1 HAD AN INITIAL CALCIUM RESULT OF 1.20 MMOL/L. THE REPEAT CALCIUM RESULT WAS 2.22 MMOL/L. SAMPLE 2 HAD AN INITIAL ALBUMIN RESULT OF 7.2 G/L. THE REPEAT ALBUMIN RESULT WAS 39.1 G/L. SAMPLE 3 HAD INITIAL RESULTS OF CALCIUM 1.18 MMOL/L AND GLUCOSE 2.69 MMOL/L. THE REPEAT RESULTS WERE CALCIUM 2.24 MMOL/L AND GLUCOSE 9.9 MMOL/L. SAMPLE 4 HAD AN INITIAL TOTAL PROTEIN RESULT OF 30.8 G/L. THE REPEAT TOTAL PROTEIN RESULT WAS 66.2 G/L. SAMPLE 5 HAD AN INITIAL CALCIUM RESULT OF 1.01 MMOL/L. THE REPEAT CALCIUM RESULT WAS 2.14 MMOL/L. THE CALCIUM, ALBUMIN, AND GLUCOSE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 577235 WITH AN EXPIRATION DATE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912770 COBAS P 612 PRE-ANALYTICAL SYSTEM AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS P612 NA
    277704 COBAS P 612 PRE-ANALYTICAL SYSTEM AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS P612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown