BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 5039191 · Received August 28, 2015

    Report

    Report Number
    1823260-2015-04043
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    May 16, 2015
    Report Date
    August 28, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    PMA / PMN Number
    K071239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE GETTING COMPLAINTS OF LOW RECOVERY FOR AN UNSPECIFIED NUMBER OF PATIENT CEREBROSPINAL FLUID SAMPLES TESTED FOR TOTAL PROTEIN URINE/CSF GEN.3 (TPUC) ON AN INTEGRA 400 PLUS ANALYZER. THE RESULTS FROM THE INTEGRA 400 PLUS ANALYZER WERE NOT CORRELATING WITH THE CLINICAL SYMPTOMS OF THE PATIENTS. RECOVERIES WERE FOUND TO BE HIGHER WHEN THE SAMPLES WERE CHECKED ON OTHER SYSTEMS. THE CUSTOMER SITE IS A "NEURO" HOSPITAL. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENT SAMPLES THAT HAD QUESTIONABLE RESULTS WHEN TESTED FOR TPUC ON THE INTEGRA 400 PLUS AS COMPARED TO EITHER THE AU2700 SYSTEM OR THE SIEMENS DIMENSION ANALYZER. OF THE DATA PROVIDED, 2 PATIENTS HAD ERRONEOUS RESULTS WHICH WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER THEN PROVIDED DATA FOR 3 ADDITIONAL PATIENT SAMPLES WHICH HAD ERRONEOUS TPUC RESULTS. OF THE THREE SAMPLES, TWO HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THESE SAMPLES WERE REPEATED ON A SIEMENS DIMENSION ANALYZER, WHICH USES THE PYROGALLOL RED METHOD. THE FIRST SAMPLE INITIALLY RESULTED AS 58 MG/DL ON THE INTEGRA 400 PLUS ANALYZER AND REPORTED OUTSIDE OF THE LABORATORY TO A PHYSICIAN. THE PHYSICIAN SENT THE SAMPLE TO ANOTHER LABORATORY FOR A CROSS CHECK ON A SIEMENS ANALYZER. THE RESULT FROM THE SIEMENS ANALYZER WAS 90 MG/DL AND THE PHYSICIAN NOTED THAT THIS RESULT CORRELATED TO THE PATIENT'S CLINICAL CONDITION. THE SECOND SAMPLE, FROM A(B)(6) OLD MALE, INITIALLY RESULTED AS 42 MG/DL WHEN TESTED ON THE INTEGRA 400 PLUS. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS TESTED ON A SIEMENS ANALYZER WHERE IT RESULTED AS 148 MG/DL. IT WAS STATED THAT PATIENT TREATMENT WAS DELAYED FOR A FEW DAYS WHILE WAITING FOR DATA FROM THE SIEMENS INSTRUMENT. IT WAS ALSO STATED THAT PATIENT TREATMENT WAS INITIATED WHILE TAKING THE SIEMENS RESULTS INTO CONSIDERATION. NO ADVERSE EVENTS WERE ALLEGED FOR THESE PATIENTS. THE INTEGRA 400 PLUS ANALYZER SERIAL NUMBER WAS (B)(4). PER CUSTOMER REQUEST, THE INTEGRA 400 PLUS WAS ADJUSTED WITH AN INSTRUMENT FACTOR. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NO EVIDENCE THE ROCHE RESULTS WERE INCORRECT. THE MOST LIKELY EXPLANATION FOR THE OBSERVED DIFFERENCE IN RESULTS IS THAT EACH ANALYZER METHOD USES DIFFERENT REFERENCE STANDARDIZATION. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572199 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS NA 60095101

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR