BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH PHENCYCLIDINE (PCP)

    MDR report key: 9251053 · Received October 29, 2019

    Report

    Report Number
    2432235-2019-00396
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 29, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LCM
    UDI-DI
    00630414596044
    PMA / PMN Number
    K163220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION AS THE CUSTOMER ALLEGED THAT PATIENT CARE WAS DELAYED IN THE REPORT (MW5090047) RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. THE REPORT DID NOT IDENTIFY THE LOT(S) IN WHICH THE CUSTOMER OBSERVED REAGENT LABELS NOT ADEQUATELY ADHERING TO REAGENT BOTTLES. SIEMENS REVIEWED INSTRUMENT DATA AND DETERMINED THAT THE ATELLICA CH PHENCYCLIDINE (PCP) IN USE ON 19-SEP-2019 WAS LOT 190042; THE LOT # WAS UPDATED BASED ON THIS INFORMATION. THE CUSTOMER ALLEGED THAT SIEMENS PROVIDED THE WORKAROUND OF TAPING REAGENT LABELS ONTO REAGENT BOTTLES TO THE CUSTOMER. HOWEVER, SIEMENS DID NOT PROVIDE THIS RECOMMENDATION TO THE CUSTOMER. THE CAUSE CANNOT BE DETERMINED BECAUSE THE USE OF TAPE IS NOT A VALIDATED SIEMENS RECOMMENDATION AND USE OF TAPE ON THE REAGENT LABEL WOULD BE CONSIDERED NON-STANDARD USE/OPERATOR ERROR. ACCORDING TO THE INSTRUMENT FILES, ON THE DAY OF THE EVENT, THERE WERE MULTIPLE REAGENT LOADER ERRORS, AND THE OPERATOR OPENED THE ANALYZER LID AND SHUT-DOWN THE ANALYZER MULTIPLE TIMES. SIEMENS DETERMINED THAT THERE WERE MULTIPLE DOWNTIME SITUATIONS AND AN ISSUE OCCURRED WITH THE REAGENT LOADING AND STORAGE SYSTEM. SIEMENS INVESTIGATED THIS ISSUE AND DETERMINED THAT THE BARCODE LABELS MAY BE LOOSELY ADHERED TO SOME OF THE ATELLICA CH REAGENT BOTTLES. IN MOST INSTANCES, THE LABEL CAN BE READ BY THE INSTRUMENT. IN ADDITION, LABELS THEMSELVES STAY FULLY ATTACHED TO THE FRONT SURFACE OF THE REAGENT BOTTLES WITH ONLY THE TAB WHICH EXTENDS OVER THE SHOULDER OF THE BOTTLES LOSING ADHERENCE. THUS, THERE IS NO IMPACT ON THE HUMAN READABLE INFORMATION WHICH CUSTOMERS USE FOR IDENTIFICATION WHILE HANDLING REAGENT BOTTLES PRIOR TO, AND AFTER, LOADING THE REAGENT BOTTLES ONTO THE ATELLICA CH ANALYZER. THERE IS NO IMPACT ON ASSAY PERFORMANCE. THERE IS NO POTENTIAL FOR INCORRECT RESULTS DUE TO THIS ISSUE. THE FDA NOTIFIED SIEMENS OF THE ISSUE BY NOTIFYING SIEMENS OF REPORT MW5090047. THE INITIAL REPORTER INFORMATION WAS EXTRACTED FROM SIEMENS COMPLAINT HANDLING SYSTEM AND THE REPORT. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, SIEMENS WAS INFORMED OF A REPORT (MW5090047) THAT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. IN THIS REPORT, THE CUSTOMER INDICATED THAT WHEN ATELLICA CH PHENCYCLIDINE (PCP) REAGENT BOTTLES ARE PLACED ONTO THE ATELLICA ANALYZER, THE REAGENT LABELS LOSE ADHERENCE TO THE BOTTLES AND COVER THE BARCODES. THE CUSTOMER'S WORK AROUND FOR THIS ISSUE WAS PLACING TAPE ON THE REAGENT BOTTLES; THE CUSTOMER STATED THAT IF THE REAGENT LABELS WERE INCORRECTLY TAPED ONTO THE BOTTLES, THE TAPE CAUSED AN INSTRUMENT MALFUNCTION. THE CUSTOMER ALLEGED THAT PATIENT CARE WAS DELAYED DUE TO AN INSTRUMENT MALFUNCTION CAUSED BY A WORK AROUND IMPLEMENTED BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE DELAY IN PATIENT CARE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043599 ATELLICA CH PHENCYCLIDINE (PCP) ATELLICA CH PHENCYCLIDINE (PCP) LCM SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH PHENCYCLIDINE (PCP) 190042 00630414596044

    Patients

    Seq Age Sex Outcome Treatment
    1