BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QMS EVEROLIMUS ASSAY

    MDR report key: 6866863 · Received September 14, 2017

    Report

    Report Number
    3010939897-2017-00002
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    July 7, 2017
    Report Date
    September 13, 2017
    Manufacturer
    MICROGENICS CORPORATION
    Product Code
    OUF
    UDI-DI
    00884883011687
    PMA / PMN Number
    K122766
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF PROBLEM: ON 21JULY2017 THE FOLLOWING INFORMATION WAS COMMUNICATED TO BECKMAN COULTER: CUSTOMER REPORTS ERRONEOUSLY LOW EVEROLIMUS (EVER) FOR ONE (1) PATIENT GENERATED BY THE AU680 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH RESULTING IN SAME RESULT. THERE WAS CHANGE/ADJUSTMENT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. INVESTIGATION AND ANALYSIS: CUSTOMER REPORTS CALIBRATION AND QUALITY CONTROLS MEETING SPECIFICATIONS ON THE DAY OF INCIDENT. NO DATA WAS PROVIDED. CUSTOMER REPORTS THE INITIAL RESULT <2 NG/ML, PATIENT WAS REDRAWN TO CONFIRMING RESULT TO <2 NG/ML. THE ERRONEOUS LOW RESULT WAS REPORTED OUT OF LABORATORY. PHYSICIAN INCREASED PATIENT DOSAGE OF EVEROLIMUS, CAUSING PATIENT TO BECOME TOXIC. SAMPLE WAS REPEATED BY REFERENCE LABORATORY RESULTING IN NORMAL LEVELS. NO DATA WAS PROVIDED. PATIENT HAD DIALYSIS TO BRING TOXIC LEVELS DOWN. THIS DID NOT RESULT IN DEATH. NO OTHER DETAILS WERE PROVIDED. APPLICATIONS SPECIALIST REVIEWED CUSTOMER PARAMETERS, FINDING MULTIPLE ASSAYS TO BE INCORRECTLY ENTERED FROM A SOURCE NOT PROVIDED BY MICROGENICS. ASSAYS INCLUDED CYCLOSPORINE (CSAL/CSAH), TACROLIMUS (TAC) AND EVEROLIMUS (EVR). APPLICATIONS SPECIALIST WALKED CUSTOMER THROUGH PROPER PARAMETER SETTING AND VALIDATED SYSTEM OPERATION WITHOUT FURTHER ISSUE. NO EVIDENCE OF SYSTEM OR REAGENT MALFUNCTION. A FOLLOW-UP WITH APPLICATIONS SPECIALIST CONFIRMS PARAMETERS WERE CORRECT DURING AND AFTER INSTALLATIONS STAGES, PROVIDING PRINTOUTS. REVIEW OF ORACLE BUSINESS INTELLIGENCE (OBI) DATABASE ON 15 AUG 2017, FINDS ANALYZER INSTALLED ON 16 FEB 2017. NO REOCCURRENCE OF THIS ISSUE HAS BEEN REPORTED. THE AVAILABLE INFORMATION SUGGESTS THE FAILURE MODE IS USE ERROR. APPLICATIONS SPECIALIST FOUND INCORRECT PARAMETER SETTING FOR MULTIPLE ASSAYS. CAUSE OF THE EVENT AND CONCLUSION: THE FAILURE MODE OF THIS EVENT IS USE ERROR. APPLICATIONS SPECIALIST FOUND INCORRECT PARAMETER SETTING FOR MULTIPLE ASSAYS. NO EVIDENCE OF REAGENT OR SYSTEM MALFUNCTION.

    Description of Event or Problem · 1

    ERRONEOUS LOW EVEROLIMUS RESULTS WITH INJURY TO PATIENT. THE CUSTOMER STATED THAT THE INSTRUMENT KEEPS AUTO DILUTING THE TEST WHEN IT HAS NOT BEEN PROGRAMED TO DO SO. ACCORDING TO THE CUSTOMER, THE REAGENT VOLUME IS SET TO ZERO. ON INVESTIGATION, THE APPS MANAGER FOUND THAT ERRONEOUS LOW EVEROLIMUS WERE GENERATED DUE TO THIS ISSUE. THE RESULT WAS <2. THE PATIENT WAS REDRAWN TO CONFIRM THE RESULT. THE RESULTS MATCHED, BUT BOTH WERE INCORRECT. THE ERRONEOUS LOW RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PHYSICIAN INCREASED DOSAGE OF EVEROLIMUS. THE PATIENT BECAME TOXIC, A SAMPLE WAS RUN AT A REFERENCE LABORATORY, AND ULTIMATELY THE PATIENT HAD TO HAVE DIALYSIS TO BRING THE LEVEL DOWN. THIS DID NOT RESULT IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645357 QMS EVEROLIMUS ASSAY EVEROLIMUS IMMUNOASSAY OUF MICROGENICS CORPORATION 0380000 00884883011687

    Patients

    Seq Age Sex Outcome Treatment
    1 Other