BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2780899 · Received October 10, 2012

    Report

    Report Number
    1823260-2012-05062
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CALIBRATION AND QUALITY CONTROL DATA WAS WITHIN RANGE AND DO NOT INDICATE A REAGENT ISSUE. PERFORMANCE DATA WAS ANALYZED AND THE DATA WAS WITHIN THE SPECIFIED RANGES. THE ALARM TRACE SHOWED NO SUSPICIOUS ALARMS. NO INSTRUMENT ISSUES WERE EVIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE HUMAN CHORIONIC GONADOTROPIN, STAT (HCG) RESULT ON THEIR E411 ANALYZER. ON (B)(6) 2012, THE PATIENT RECEIVED A NEGATIVE BHCG RESULT FROM A BIOEASY QUALITATIVE TEST. ON (B)(6) 2012, THE PATIENT HAD A NEW SAMPLE TESTED ON THE E411 ANALYZER AND THE RESULT WAS 153.3 MIU/ML ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED TO THE PATIENT. THE PATIENT SHOWED HER DOCTOR WHO DECIDED TO SUSPEND SOME MEDICATION DUE TO THE POSITIVE RESULT. THE CUSTOMER ALSO PROVIDED A PRINT OUT FROM THEIR LABORATORY INFORMATION SYSTEM (LIS) INDICATING THIS RESULT WAS PRODUCED USING THE BHCG REAGENT, LOT NUMBER AND EXPIRATION DATE NOT PROVIDED, ON AN ELECSYS 2010 ANALYZER, SERIAL NUMBER NOT PROVIDED. CLARIFICATION HAS BEEN REQUESTED. ON (B)(6) 2012, THE PATIENT HAD ANOTHER SAMPLE COLLECTED AND THE QUALITATIVE BHCG TEST PERFORMED WAS NEGATIVE. ON (B)(6) 2012, ANOTHER PATIENT SAMPLE WAS COLLECTED. ON (B)(6) 2012, THE PATIENT SAMPLE WAS TESTED ON THE E411 ANALYZER AND THE RESULT WAS 0.915 MIU/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER ALSO PROVIDED AN LIS PRINT OUT INDICATING THIS RESULT WAS PRODUCED USING THE HCGB REAGENT ON AN ELECSYS 2010 ANALYZER. CLARIFICATION HAS BEEN REQUESTED. ON (B)(6) 2012, THE PATIENT SAMPLE THAT PRODUCED THE POSITIVE HCG RESULT WAS RETESTED ON THE E411 ANALYZER AND THE RESULT WAS 0.810 MIU/ML ACCOMPANIED BY A DATA FLAG. THE NEGATIVE RESULTS WERE CONSIDERED CORRECT. THE DISCONTINUATION OF THE MEDICATION DID NOT LEAD TO A CHANGE IN BEHAVIOR, AND THERE WAS NO REPORTED MENTAL OR PHYSICAL INJURY TO THE PATIENT. THE HCG REAGENT LOT NUMBER WAS 166973 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1