BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2770977 · Received October 3, 2012

    Report

    Report Number
    1823260-2012-04943
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TINA-QUANT IGA GEN.2, TINA-QUANT IGG GEN.2, AND TINA-QUANT IGM GEN.2 RESULTS ON THEIR P- MODULE. THE CUSTOMER WAS QUESTIONING RESULTS FOR TEN PATIENTS, BUT WAS ONLY ABLE TO PROVIDE DATA FOR SEVEN PATIENTS WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE REPEAT TESTING WAS PERFORMED ON THE INITIAL P-MODULE (A) AND ANOTHER P-MODULE (B), SERIAL NUMBER (B)(4). AFTER THE INITIAL TESTING, THE SAMPLES WERE SENT FOR ELECTROPHORESIS. AFTER THE ELECTROPHORESIS WAS PERFORMED, THE TECHNICIAN QUESTIONED THE INITIAL RESULTS. THE FIRST PATIENT'S INITIAL IGA RESULT WAS 115 MG/DL. ON (B)(6) 2012, THE REPEAT RESULT WAS 7 MG/DL. THE CUSTOMER STATED THE SAMPLE WAS TESTED A THIRD TIME WITH APPROXIMATELY THE SAME VALUE AS THE SECOND RESULT. BOTH ANALYZERS WERE USED FOR REPEAT TESTING, BUT THE CUSTOMER WAS UNSURE WHICH ANALYZER GENERATED THE SECOND AND THIRD RESULTS. THE SECOND PATIENT'S INITIAL IGM RESULT WAS 328 MG/DL. ON (B)(6) 2012, THE REPEAT RESULT WAS 22 MG/DL. THE CUSTOMER STATED THE SAMPLE WAS TESTED A THIRD TIME WITH APPROXIMATELY THE SAME VALUE AS THE SECOND RESULT. BOTH ANALYZERS WERE USED FOR REPEAT TESTING, BUT THE CUSTOMER WAS UNSURE WHICH ANALYZER GENERATED THE SECOND AND THIRD RESULTS. THE THIRD PATIENT'S INITIAL IGM RESULT WAS 115 MG/DL. ON (B)(6) 2012, THE REPEAT RESULTS FROM ANALYZER A WERE 7 MG/DL ACCOMPANIED BY A DATA FLAG AND 10 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULTS FROM ANALYZER B WERE 7 MG/DL ACCOMPANIED BY A DATA FLAG AND 10 MG/DL ACCOMPANIED BY A DATA FLAG. THE FOURTH PATIENT'S INITIAL IGA RESULT WAS 37 MG/DL. ON (B)(6) 2012, THE REPEAT RESULTS FROM ANALYZER A WERE 7 MG/DL ACCOMPANIED BY A DATA FLAG AND 7 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULTS FROM ANALYZER B WERE 6 MG/DL ACCOMPANIED BY A DATA FLAG AND 7 MG/DL ACCOMPANIED BY A DATA FLAG. THE FOURTH PATIENT'S INITIAL IGM RESULT WAS 266 MG/DL. ON (B)(6) 2012, THE REPEAT RESULTS FROM ANALYZER A WERE 3 MG/DL ACCOMPANIED BY A DATA FLAG AND 6 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULTS FROM ANALYZER B WERE 2 MG/DL ACCOMPANIED BY A DATA FLAG AND 6 MG/DL ACCOMPANIED BY A DATA FLAG. THE FIFTH PATIENT'S INITIAL IGM RESULT WAS 50 MG/DL. ON (B)(6) 2012, THE REPEAT RESULTS FROM ANALYZER A WERE 3 MG/DL ACCOMPANIED BY A DATA FLAG AND 5 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULTS FROM ANALYZER B WERE 3 MG/DL ACCOMPANIED BY A DATA FLAG AND 6 MG/DL ACCOMPANIED BY A DATA FLAG. THE SIXTH PATIENT, BORN ON (B)(6) 1931, HAD AN INITIAL IGM RESULT OF 41 MG/DL. ON (B)(6) 2012, THE REPEAT RESULTS FROM ANALYZER B WERE 6 MG/DL ACCOMPANIED BY A DATA FLAG AND 8 MG/DL ACCOMPANIED BY A DATA FLAG. THE SEVENTH PATIENT HAD AN INITIAL IGM RESULT OF 36 MG/DL. ON (B)(6) 2012, THE REPEAT RESULTS FROM ANALYZER B WERE 0 MG/DL ACCOMPANIED BY A DATA FLAG, 3 MG/DL ACCOMPANIED BY A DATA FLAG, 0 MG/DL ACCOMPANIED BY A DATA FLAG, AND 3 MG/DL ACCOMPANIED BY A DATA FLAG. THE SEVENTH PATIENT'S INITIAL IGG RESULT OF 760 MG/DL. ON (B)(6) 2012, THE REPEAT RESULT FROM ANALYZER B WAS 1624 MG/DL ACCOMPANIED BY A DATA FLAG. THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE CORRECT, BUT DID NOT HAVE ACCESS TO THE ACTUAL CORRECTED RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE IGA REAGENT LOT NUMBER WAS 65189501 AND THE EXPIRATION DATE WAS 06/30/2013. THE IGM REAGENT LOT NUMBER WAS 65409301 AND THE EXPIRATION DATE WAS 07/31/2013. THE IGG REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND CONTAMINATION OF THE SAMPLE PATHWAY CAUSING THE ELEVATED RESULTS. HE PERFORMED CORRECTIVE MAINTENANCE AND DECONTAMINATED THE SAMPLE AND REAGENT PATHWAYS. HE ADJUSTED THE GEAR PUMP PRESSURE AND VERIFIED ALIGNMENTS. THE CALIBRATION, QUALITY CONTROL, AND A PRECISION RUN WERE WITHIN THE CUSTOMER'S SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1