BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1628392 · Received March 11, 2010

    Report

    Report Number
    1823260-2010-01530
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    February 24, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE REPLACEMENT OF THE SAMPLE PROBE, THE CUSTOMER HAS BEEN RUNNING THE SAMPLES WITH ROUTINE DUPLICATES ON A TIGHTER THAN NORMAL RERUN LIMIT TO VERIFY CORRECT RERUN RESULTS AND THESE HAVE PROVED TO BE REPRODUCIBLE. ADDITIONALLY, THERE HAVE BEEN NO FURTHER QUESTIONS FROM THE HEMATOLOGISTS NOR GP'S. REPLACING THE SAMPLE PROBE APPEARED TO HAVE RESOLVED THE DISCREPANT RESULTS. THE DISCREPANT IGM RESULTS WERE NOT REPORTED OUTSIDE THE LAB. .

    Description of Event or Problem · 1

    CUSTOMER HAD AN ON-GOING ISSUE WITH DISCREPANT IGM RESULTS AND PROVIDED THREE EXAMPLES. THE INITIAL AND RERUN RESULTS WERE BOTH TESTED ON THE SAME ANALYZER, NO UNITS OF MEASURE PROVIDED. SAMPLE 1, INITIAL IGM RESULT 4.73, RERUN 6.2; RERUN TWICE ON (B) (6) 2010 GEVE 4.47 AND 4.48. SAMPLE 2, INITIAL IGM RESULT 3.34, RERUN 4.6; RERUN TWICE ON (B) (6) 2010 GAVE 3.6 AND 3.8. SAMPLE 3, INITIAL IGM RESULT 4.1, RERUN 5.4; RERUN TWICE ON GAVE (B) (6) 2010 AND 2.98 AND 2.94. NO REAGENT LOT WAS PROVIDED. SITE DOES NOT USE RACK INSERTS. CUSTOMER INDICATED SOME OF THE INITIAL RESULTS WERE REPORTED AND THE MAJORITY WERE QUERIED EITHER BY THE HEMATOLOGIST OR GENERAL PRACTITIONER. THE POSSIBILITY DOES EXIST THAT SOME RESULTS MAY NOT HAVE BEEN QUERIED; HOWEVER, THIS IS UNKNOWN BY THE LAB. THE APPLICATIONS SPECIALIST VERIFIED ANALYZER SETTINGS AND SUGGESTED SAMPLE PROBE REPLACEMENT. CUSTOMER CARRIED OUT SAMPLE PROBE REPLACEMENT AND PERFORMED ALIGNMENTS. CUSTOMER HAS HAD NO FURTHER OCCURRENCES OF DISCREPANT IGM RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6800 SYSTEM HAD MIXED UP IMAGES IN THE IMAGE DIRECTORY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1