BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG + BETA TEST SYSTEM

    MDR report key: 13534931 · Received February 15, 2022

    Report

    Report Number
    1823260-2022-00379
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 25, 2022
    Report Date
    July 8, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    UDI-DI
    04015630939732
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, THE FOLLOWING RESULTS WERE OBTAINED FROM THE NEW SAMPLE RECEIVED BY THE CUSTOMER: THE PATIENT¿S INITIAL RESULT FROM THE ANALYZER WAS <0.2 IU/L. THE REPEAT RESULT FROM THE ALINITY I WAS 48.16 MIU/ML. THE RESULT FROM A RAPID QUALITATIVE TEST WAS POSITIVE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2021 AND MET ACCEPTANCE CRITERIA WITH NO ALARMS. THE QC MET ACCEPTANCE CRITERIA. THERE IS NO INDICATION FOR A PERFORMANCE ISSUE OF THE REAGENT OR INSTRUMENT. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE FIELD SERVICE ENGINEER (FSE) FOUND NO CAUSE FOR THE EVENT. THE SAMPLE WAS REPEATED ON BOTH PLATFORMS TO EXCLUDE A SAMPLE MISMATCH. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION NOTED THAT THE CUSTOMER WAS ABLE TO CONFIRM THE RESULTS UPON REPETITION. THE INVESTIGATION CONFIRMED THE CUSTOMER'S RESULTS USING ELECSYS HCG STAT AND ELECSYS F-BHCG ASSAYS. THE INVESTIGATION NOTED THAT THE EXPECTED INCREASE IN HCG AFTER ONE WEEK OF SAMPLE DRAWING WAS NOT SEEN. THE INVESTIGATION DID NOT IDENTIFY ANY INTERFERENT AGAINST THE STREPTAVIDIN (SA) LABEL. A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    IN MFR REPORT REF #1823260-2022-00379-01, H10 - ADDTL MFG NARRATIVE SHOULD HAVE BEEN: "ON (B)(6)-2022, THE FOLLOWING RESULTS WERE OBTAINED FROM THE NEW SAMPLE RECEIVED BY THE CUSTOMER: THE RESULT FROM THE ALINITY CI-SERIES AT 9:43 AM WAS 48.16 MIU/ML. THE INITIAL RESULT FROM THE ANALYZER AT 10:57 WAS 0.200 IU/L WITH A DATA FLAG. THE RESULT FROM A RAPID QUALITATIVE TEST WAS POSITIVE. THE INVESTIGATION IS ONGOING." INSTEAD OF: "ON (B)(6)2022, THE FOLLOWING RESULTS WERE OBTAINED FROM THE NEW SAMPLE RECEIVED BY THE CUSTOMER: THE PATIENT¿S INITIAL RESULT FROM THE ANALYZER WAS <0.2 IU/L. THE REPEAT RESULT FROM THE ALINITY I WAS 48.16 MIU/ML. THE RESULT FROM A RAPID QUALITATIVE TEST WAS POSITIVE. THE INVESTIGATION IS ONGOING."

    Description of Event or Problem · 0

    THERE WAS A COMPLAINT OF A QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR 1 PATIENT TESTED WITH COBAS E801 MODULE SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT¿S SAMPLE WAS REPEATED ON AN ALINITY CI-SERIES. THE PATIENT¿S INITIAL RESULT WAS 0.200 IU/L AND WAS ACCOMPANIED BY A DATA FLAG; THE REPEAT WAS 49.90 MIU/ML AND HAD A POSITIVE INTERPRETATION. A QUALITATIVE, VISUAL TEST WAS PERFORMED AND WAS POSITIVE. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND "THE SAME RESULTS WERE OBTAINED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584830 ELECSYS HCG + BETA TEST SYSTEM SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA 55018801 04015630939732

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown