BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 19059821 · Received April 8, 2024

    Report

    Report Number
    1823260-2024-01064
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 13, 2024
    Report Date
    July 12, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    07613336121535
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D4 LOT NO WAS UPDATED. ON 17-MAY-2024, THE CUSTOMER PROVIDED ADDITIONAL DATA REGARDING THE EVENT: ON (B)(6) 2024: THE FIFTH REPEAT RESULT WAS 0.49 G/L. THE INVESTIGATION REVIEWED THE LAST CALIBRATION PERFORMED ON 04-MAR-2024 AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC DATA AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE INSTRUMENT'S LOG FILES. THE LOG FILES HAD MULTIPLE "ABNORMAL ASPIRATION (SAMPLE PIPETTOR S1)" ALARMS. THIS ALARM IS AN INDICATION OF PREANALYTIC/SAMPLE HANDLING-RELATED ISSUES. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE. THE INVESTIGATION RULED OUT A GENERAL REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS PRO C 503 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION REVIEWED THE LAST CALIBRATION PERFORMED ON (B)(6) 2024; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC DATA FROM THE ANALYZER'S LOG FILES; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE ALARM TRACE (LAST 30 DAYS) FROM THE ANALYZER'S LOG FILES; THE MOST FREQUENT ALARM WAS "ABNORMAL ASPIRATION (SAMPLE PIPETTOR S1)" ALARM. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE TPUC3 (TOTAL PROTEIN URINE/CSF GEN.3) RESULT FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER STATED THAT THE MICROALBUMIN RESULT OF 185 MG/L WAS INCONSISTENT WITH THE INITIAL TPUC3 RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.14 G/L. THE FIRST REPEAT RESULT WAS 0.45 G/L. THE SECOND REPEAT RESULT WAS 0.45 G/L. THE THIRD REPEAT RESULT WAS 0.45 G/L. THE FOURTH REPEAT RESULT WAS REPORTED AS 0.48 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121674 TOTAL PROTEIN URINE/CSF GEN.3 URINE/CSF TOTAL PROTEIN TEST JIQ ROCHE DIAGNOSTICS 747700 07613336121535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown