BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 501 MODULE

    MDR report key: 14335239 · Received May 9, 2022

    Report

    Report Number
    1823260-2022-01311
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 13, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAD BEEN HAVING ISSUES WITH QC RESULTS ON BOTH MODULES SINCE APPROXIMATELY ON (B)(6) 2022. ON (B)(6) 2022 ROCHE FIELD PERSONNEL CLEANED AND CALIBRATED BOTH MODULES AND THE QC RESULTS RETURNED TO NEAR AVERAGE. ON (B)(6) 2022 THE FIELD SERVICE ENGINEER (FSE) USED QC MATERIAL AND PERFORMED REPEAT TESTING 30 TIMES AND THEN REPLACED ALL THE CARTRIDGES OF MODULE 2. CALIBRATION AND QC WERE PERFORMED. SINCE THE CARTRIDGES WERE REPLACED ON MODULE 2, THE CUSTOMER HAS HAD NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR INVESTIGATION. BASED ON THE DATA PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 5 PATIENT SAMPLES TESTED FOR K ELECTRODE (K) BETWEEN TWO COBAS 6000 C (501) MODULES WITH SERIAL NUMBERS (B)(4) (MODULE 1) AND 1007-04 (MODULE 2). THE RESULTS FROM MODULE 1 WERE BELIEVED TO BE CORRECT. PATIENT 1 RESULT FROM MODULE 1 WAS 4.4 MMOL/L. THE RESULT FROM MODULE 2 WAS 3.6 MMOL/L. PATIENT 2 RESULT FROM MODULE 1 WAS 4.1 MMOL/L. THE RESULT FROM MODULE 2 WAS 3.4 MMOL/L. PATIENT 4 RESULT FROM MODULE 1 WAS 4.2 MMOL/L. THE RESULT FROM MODULE 2 WAS 3.5 MMOL/L. PATIENT 5 RESULT FROM MODULE 1 WAS 4.0 MMOL/L. THE RESULT FROM MODULE 2 WAS 3.3 MMOL/L. PATIENT 6 RESULT FROM MODULE 1 WAS 4.3 MMOL/L. THE RESULT FROM MODULE 2 WAS 3.5 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE K ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804646 COBAS C 501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown