BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 6847704 · Received September 7, 2017

    Report

    Report Number
    1823260-2017-01920
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 21, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CHANGED VALVES, NOZZLE ASSEMBLIES, REAGENT PROBES, AND RINSE TUBING. AFTER THESE ACTIONS, THE CUSTOMER CONTINUED TO HAVE WRONG PATIENT RESULTS. IT WAS ASKED, BUT NO DETAILS COULD BE PROVIDED REGARDING AFFECTED PATIENT RESULTS. THE INCORRECT RESULTS DID NOT CAUSE HARM TO PATIENTS SINCE TESTING IS PERFORMED IN DUPLICATE AND THE INCORRECT RESULTS ARE NOT REPORTED OUTSIDE OF THE LABORATORY. THE FIELD SERVICE ENGINEER THEN VERIFIED THE GEAR PUMP PRESSURE. HE EXCHANGED THE GEAR PUMP HEAD AND AFTER THIS ACTION, THERE WERE NO FURTHER ISSUES REPORTED WITH PATIENT RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6) - (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FIVE PATIENT SAMPLES TESTED FOR CA2 CALCIUM GEN.2 (CALCIUM) AND PHOS INORGANIC PHOSPHORUS (PHOSPHORUS) ON A MODULAR ANALYTICS P-MODULE (PMOD) ANALYZER. THE SAMPLES WERE REPEATED ON A COBAS 6000 C (501) MODULE - C501 AND THE RESULTS FROM THE C501 ANALYZER WERE BELIEVED TO BE CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO ISSUES WITH ANY OTHER TESTS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE CALCIUM R1 REAGENT LOT NUMBER WAS 167209. THE R1 REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE CALCIUM R2 REAGENT LOT NUMBER WAS 165614, WITH AN EXPIRATION DATE OF 31-OCT-2017. THE PHOSPHORUS REAGENT LOT NUMBER WAS 211342, WITH AN EXPIRATION DATE OF 30-APR-2018. PRECISION STUDIES WERE PERFORMED ON THE ANALYZER. THE FIELD SERVICE ENGINEER ADJUSTED WASHING. HE ALSO ADJUSTED PROBES, REAGENTS, AND THE MIXER. HE CHANGED THE SAMPLE PROBE AND ADJUSTED A REAGENT PROBE THAT WAS MISADJUSTED. DIRT WAS FOUND UNDER CUVETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629794 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS P MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1