BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7464014 · Received April 26, 2018

    Report

    Report Number
    1823260-2018-01292
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 12, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED SAMPLE HAD AN AFP RESULT OF 1210 NG/ML ACCOMPANIED BY A DATA FLAG ON (B)(6) 2018, PRIOR TO THE RESULT OF 3801 NG/ML. THE SAMPLE ALSO HAD AN AFP RESULT OF 1210 NG/ML ACCOMPANIED BY A DATA FLAG ON (B)(6) 2018 PRIOR TO THE RESULT OF 2195 NG/ML. IT WAS BELIEVED THAT THE ERRONEOUS SAMPLE RESULT WAS CAUSED BY CARRYOVER FROM A SAMPLE THAT HAD A HIGH CA 19-9 TEST RESULT. EXPERIMENTS WERE PERFORMED WHERE A HIGHER CONCENTRATION CA 19-9 SAMPLE WAS TESTED BEFORE THE COMPLAINED SAMPLE. THE COMPLAINED SAMPLE AFP RESULT WHEN DILUTED WAS STILL 2195 NG/ML.

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE CALIBRATION DATA, SIGNALS FOR ONE CALIBRATOR LEVEL WERE OK. SIGNALS FOR THE SECOND CALIBRATOR LEVEL WERE LOWER THAN EXPECTED. NO ISSUES WERE SEEN WITH QUALITY CONTROLS. UPON REVIEW OF THE ALARM TRACE, NO ALARMS RELATED TO THE INCREASED AFP RESULT FROM (B)(6) 2018 WERE OBSERVED. FOR THE SAMPLE MEASUREMENT OF 2195 NG/ML, THE SAMPLE WAS DILUTED 50 TIMES. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. A GENERAL PRODUCT PROBLEM COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4). MEDWATCH FIELD E1 FACILITY NAME - THE FULL FACILITY NAME WAS PROVIDED AS "HEILONGJIANG DIAN CLINICAL LABORATORIES CO., LTD. HEILONGJIANG DEAN MEDICAL LABORATORY CO., LTD.". MEDWATCH FIELD E1 ADDRESS WAS PROVIDED AS "6TH FLOOR, UNIT 8, BUILDING 5, TAIHU NORTH ROAD, CHUANGYE BUILDING, YINGBIN ROAD, HIGH-TECH ZONE , HARBIN". (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS AFP ASSAY (AFP) ON A COBAS 6000 E 601 MODULE (E601). THE SAMPLE WAS DILUTED TIMES 50 AND TESTED FOR AFP, RESULTING AS 3801 NG/ML. THE 3801 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018, THE PATIENT STATED THAT THEY DID NOT TRUST THE VALUE. THE SAMPLE WAS REPEATED, RESULTING AS 2195 NG/ML. THE SAMPLE WAS ALSO TESTED AT ANOTHER HOSPITAL ON A SECOND E601 ANALYZER AFTER DILUTING THE SAMPLE 100 TIMES, RESULTING AS 2186 NG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE AFP REAGENT LOT NUMBER WAS 267272, WITH AN EXPIRATION DATE OF 16-APR-2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308314 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1