BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2962143 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00891
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. CALIBRATION AND QUALITY CONTROLS WERE WITIN EXPECTATION. THERE WAS NO INDICATED OF A REAGENT ISSUE. ANALYZER PERFORMANCE CHECKS WERE WITHIN SPECIFICATION. THE OUT OF SPECIFICATION LABORATORY HUMIDITY AND WORN RACK ADAPTERS ARE POSSIBLE CAUSES OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN PLUS THE SS-SUBUNIT (HCG+SS). THE SAMPLE INITIALLY RESULTED AS 0.100 MIU/ML ACCOMPANIED BY A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE ER DOCTOR QUESTIONED THE RESULT AS A FETAL HEARTBEAT WAS DETECTED. THE SAMPLE WAS THEN REPEATED AND RESULTED AS 10,000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN AUTOMATICALLY REPEATED BY THE ANALYZER WITH A DILUTION, RESULTING AS 64,049 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE HCG+SS REAGENT LOT NUMBER WAS 16758402 WITH AN EXPIRATION DATE OF 07/31/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE HUMIDITY WAS BELOW THE RANGE STATED BY THE MANUFACTURER. HE DETERMINED THAT HUMIDITY WAS TOO LOW, CAUSING SHORT SAMPLING DUE TO STATIC. HE ALSO NOTED THAT IT IS POSSIBLE THE SAMPLE CONTAINER WAS LEANING INSIDE OF THE RACK. HE PERFORMED A PRODUCT REPLACEMENT OF RACK INSERTS FOR THE CUSTOMER IN ORDER TO PREVENT POSSIBLE SAMPLE TUBE LEANING. HE ALSO ASKED THE CUSTOMER TO NOTIFY MAINTENANCE, SO THE HUMIDITY CAN BE RAISED IN THE LABORATORY. HE RAN PERFORMANCE TESTING AND THIS PASSED WITHIN SPECIFICATIONS. THE CUSTOMER VERIFIED QUALITY CONTROL AND PATIENT RECOVERY. THE FIELD SERVICE REPRESENTATIVE LATER CLARIFIED THAT THE CUSTOMER DID USE RECOMMENDED RACK ADAPTERS, BUT THEY HAD BECOME WORN, ALLOWING THE TUBES TO LEAN SLIGHTLY IN THEIR POSITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66107 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR ACETAMINOPEN (EVERY 4 HOURS)| PROMETHAZINE (EVERY 6 HOURS)