BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 3934014 · Received July 15, 2014

    Report

    Report Number
    1823260-2014-05234
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A GENERAL REAGENT ISSUE COULD NOT BE DETECTED BASED ON THE PROVIDED CALIBRATION DATA. FROM THE ALARM DOCUMENTED, THERE MAY HAVE BEEN FOAM OR BUBBLES ON THE SYSTEM REAGENTS PROCELL AND CLEANCELL WHICH MAY HAVE CAUSED THE ISSUE. ANOTHER POSSIBLE CAUSE OF THE ISSUE COULD BE THE CUSTOMER NOT USING THE SAMPLE TUBE RACK ADAPTERS WHICH ENSURE A CORRECT POSITIONING OF THESE TUBES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). IT WAS STATED THE PATIENT STARTED THE MEDICATIONS ON (B)(6). THE YEAR OF THE MEDICATION START WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT. THE RESULT FROM A SAMPLE IN (B)(6) 2014 WAS 23 UUI/ML. ON (B)(6) 2014, THE RESULT FOR THE PATIENT WAS 53.08 UUI/ML. THE DOCTOR DIDN'T ACCEPT THIS RESULT DUE TO THE DISCREPANT CLINICAL STATUS. THE TECHNICIAN SENT THE SAMPLE TO ANOTHER LAB WHICH RUNS TSH ON AN ABBOTT ARCHITECT AND THE RESULT WAS 38.03 UUI/ML. A SECOND SAMPLE WAS DRAWN ON (B)(6) 2014 AND THE RESULT WAS 15 UUI/ML. ANOTHER SAMPLE WAS DRAWN (B)(6) 2014 AND THE TSH RESULT WAS 53.17 UUI/ML. THE TECHNICIAN SENT THIS SAMPLE TO ANOTHER LABORATORY WHERE IT WAS TESTED ON THREE DIFFERENT ANALYZERS. THE RESULT ON A COBAS E 602 ANALYZER WAS 45.59 UUI/ML. THE RESULT ON AN ABBOTT ANALYZER WAS 37 UUI/ML. THE RESULT ON A SIEMENS ANALYZER WAS 39 UUI/ML. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. ALL OF THE RESULTS FROM THE ELECSYS 2010 ANALYZER WERE REPORTED TO THE DOCTOR. THERE WERE NO DEATH, INJURY, ILLNESS, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. IT WAS UNKNOWN IF THE PATIENT WAS HARMED BY ANY ACTIONS TAKEN. THE TSH REAGENT LOT NUMBER WAS 177538 WITH AN EXPIRATION DATE OF (B)(6) 2014. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE TUBE RACK ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412071 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(6)| HIDROCORTISOL