BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK HCG+BETA II ELECSYS, COBAS E

    MDR report key: 977952 · Received January 10, 2008

    Report

    Report Number
    1823260-2008-00375
    Event Type
    Malfunction
    Date Received
    January 10, 2008
    Date of Event
    December 5, 2007
    Report Date
    January 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FIFTEEN PTS WITH DISCREPANT HCG RESULTS. PT #1, INITIAL 15 IU/L; REPEATED TWICE GIVING <5 IU/L EACH TIME. PT #2, INITIAL 42 IU/L; REPEATED THREE TIMES GIVING <5 IU/L EACH TIME. PT #3 INITIAL 30 IU/L; REPEATED TWICE GIVING < 5 IU/L EACH TIME. PT #4, INITIAL 18 IU/L; REPEATED ONCE GAVE <5 IU/L. PT #5, INITIAL 75 IU/L; REPEATED TWICE GIVING <5 IU/L EACH TIME. PT #6, INITIAL 54 IU/L; REPEATED TWICE GIVING <5 IU/L EACH TIME. PT #7, INITIAL 207 IU/L; REPEATED ONCE GAVE < 5 IU/L. PATIENT #8, INITIAL 74 IU/L; REPEATED FOUR TIMES GIVING 4.16 AND <5 IU/L RESPECTIVELY. PT #9, INITIAL 23 IU/L; REPEATED ONCE GAVE <5 IU/L. PATIENT #10, INITIAL 16199 IU/L; REPEAT GAVE 18342 IU/L; SAME SAMPLE DILUTED AND REPEATED TWICE GIVING 9630 AND 8434 IU/L. PT #11, INITIAL 4811 IU/L; REPEATED TWICE GAVE 5244 AND 3374 IU/L. PT #12, INITIAL 5749 IU/L; REPEATED THREE TIMES GIVING 6318, 4372 & 12250 IU/L. PT #13, INITIAL RESULT GAVE 14140 IU/L; SAMPLE DILUTED AND REPEATED TWICE GIVING 8677 AND 8337 IU/L. PT #14, INITIAL 16 IU/L; REPEAT GAVE 9 IU/L. PT #15, INITIAL RESULT GAVE 401 IU/L; REPEAT GAVE 234 IU/L. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK HCG+BETA II ELECSYS, COBAS E IMMUNOCHEMISTRY ANALYZER - JJE DHA ROCHE DIAGNOSTICS E2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK