BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1712369 · Received June 7, 2010

    Report

    Report Number
    1823260-2010-03373
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DATA PROVIDED DEMONSTRATES CALIBRATION AND QUAILTY CONTROLS WERE WITHIN SPECIFICATION. ASSAY PEFORMANCE CHECKS WERE ALSO WITHIN SPECIFICATION. IT WAS DETERMINED SAMPLE PRE-ANALYTICAL ISSUES WERE THE MOST LIKELY CAUSE FOR THE LOW RESULT. THE PATIENT WAS NOT TREATED BASED ON THE INITIAL RESULT SINCE THIS RESULT WAS QUESTIONED AGAINST THE ULTRASOUND. THE PATIENT WAS PREGNANT IN (B)(6) ACCORDING TO ULTRASOUND INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING LITHOTRIPSY THE DEVICE PULL WIRE BROKE AND THE TIP OF THE BASKET DID NOT DETACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE ACCOUNT REPORTED THAT AN ALLIANCE HANDLE WAS USED DURING THE LITHOTRIPSY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    THE USER STATED THEY HAD A DISCREPANT HCG RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 1.21 MIU/ML WITH A DATA FLAG WHICH WAS REPORTED. THE PATIENT WAS IN THE ER AND APPEARED TO BE (B) (6) PREGNANT PER AN ULTRASOUND. THE ER CONTACTED THE LAB QUESTIONING THE HCG RESULT. THE USER REPEATED THE ORIGINAL SAMPLE ON THE E601 ANALYZER WITH A RESULT OF >10,000 MIU/ML. THE SAMPLE WAS THEN DILUTED AND GENERATED A RESULT OF 204532 MIU/ML WITH A DATA FLAG. A SECOND SAMPLE DRAWN AT THE SAME TIME AS THE ORIGINAL WAS TESTED ON THE E411 AND THE RESULT WAS >10,000 MIU/ML AND 202965 MIU/ML WHEN DILUTED. NO TREATMENT WAS PROVIDED, ALTERED OR WITHHELD DUE TO THE ERRONEOUS RESULT AS THE RESULT WAS QUESTIONED BECAUSE OF THE ULTRASOUND. THE HCG REAGENT LOT NUMBER WAS 15449601. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND CHECKED THE ANALYZER. TO VERIFY THE INSTRUMENT OPERATION, HE RAN PERFORMANCE TESTS AND CONTROLS WITH RESULTS WITHIN SPECIFICATIONS.

    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
    1 018 YR