BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 20546329 · Received October 28, 2024

    Report

    Report Number
    1823260-2024-03105
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 30, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALBUMIN REAGENT LOT NUMBER IS 802832. THE GLUCOSE REAGENT LOT NUMBER IS 779013. THE CHOLESTEROL REAGENT LOT NUMBER IS 782419. THE TOTAL BILIRUBIN REAGENT LOT NUMBER WAS NOT PROVIDED. THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DETERMINED THE SAMPLE PROBE COATED WITH GEL HAD CAUSED THE EVENT. HE REPLACED THE PROBE, PERFORMED FLUIDICS, ADJUSTED THE AMPLE PROBE, AND VERIFIED THE ANALYZER'S PERFORMANCE THROUGH A HARDWARE CHECK. THE CUSTOMER PERFORMED QC WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE GLUCOSE HK GEN.3 AND CHOLESTEROL GEN.2 CALIBRATION DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE CHOLESTEROL GEN.2 QC DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE INVESTIGATION REVIEWED THE GLUCOSE HK GEN.3 QC DATA; THE RESULTS WERE GREATER THAN -2 STANDARD DEVIATIONS. THIS MAY INDICATE A PERFORMANCE ISSUE WITH THE REAGENT. THE INVESTIGATION REVIEWED THE ALARM TRACE; THE TRACE HAD NUMEROUS "PROCELL SHORT", "CLEANCELL SHORT", AND "QC RESULT: OUT OF RANGE" ALARMS. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE HK GEN.3 (GLUC3), ALBUMIN GEN.2 (ALB2), CHOLESTEROL GEN.2 (CHOL2), AND TOTAL BILIRUBIN RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY WERE AUTO-REPEATED BECAUSE THEY HAVE SET RULES IN COBAS INFINITY. SAMPLE 1, THE INITIAL GLUCOSE HK GEN.3 RESULT WAS 21.2 MG/DL, THE REPEAT RESULT WAS 88.4 MG/DL. THE INITIAL CHOLESTEROL GEN.2 RESULT WAS 76.4 MG/DL. THE REPEAT RESULT WAS 213 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT. SAMPLE 2, THE INITIAL ALB BCG GEN.2 RESULT WAS 0.9 G/DL. THE REPEAT RESULT WAS 4.1 G/DL. THE INITIAL GLUCOSE HK GEN.3 RESULT WAS 11 MG/DL. THE FIRST REPEAT RESULT WAS 86 MG/DL. THE SECOND REPEAT RESULT WAS 74 MG/DL. THE THIRD REPEAT RESULT WAS 85 MG/DL. SAMPLE 3, THE INITIAL CHOLESTEROL GEN. 2 RESULT WAS 76 MG/DL. THE REPEAT RESULT WAS 213 MG/DL. THE INITIAL TOTAL BILIRUBIN RESULT WAS <0.2 MG/DL. THE REPEAT RESULT WAS 0.5 MG/DL. SAMPLE 4, THE INITIAL ALB BCG GEN.2 RESULT WAS 2.0 G/DL. THE REPEAT RESULT WAS 4.6 G/DL. THE INITIAL GLUCOSE HK GEN.3 RESULT WAS 80 MG/DL. THE REPEAT RESULT WAS 195 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964255 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male