BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT REALTIME CMV AMPLIFICATION KIT

    MDR report key: 16954937 · Received May 18, 2023

    Report

    Report Number
    3005248192-2023-00178
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    PAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ELEVATED COMPLAINT INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    CORRECTED D4 LOT NUMBER AND EXPIRATION DATE. CORRECTED H4 DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. NO ABNORMAL AMPLIFICATION CURVES WERE IDENTIFIED, AND THE ASSAY IS PERFORMING AS EXPECTED WITH CORRECT INTERPRETATIONS. THE VALIDITY OF THE RUNS MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE AMPLIFICATION CURVES FOR THE CMV TARGET AND INTERNAL CONTROL ARE NORMAL IN BOTH BASELINED AND RAW DATA. THE RESULTS FROM THE REALTIME CMV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE FILE SAMPLE TESTING SHOWED ABBOTT REALTIME CMV AMPLIFICATION REAGENT KIT (LIST 05N23-90) LOT 382113 PERFORMED AS EXPECTED. THERE WERE NO INSTANCES OF FALSE POSITIVE SAMPLES AND THE QUANTITATION OF NEGATIVE AND POSITIVE SAMPLES IN THE TEST WAS WITHIN SPECIFICATIONS. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ABBOTT REALTIME CMV AMPLIFICATION REAGENT KIT (LIST 05N23-90) LOT 382113 WAS PERFORMED. THE MANUFACTURING PACKETS WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT COMPONENTS. NO ISSUES WERE IDENTIFIED. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE PRODUCTS PASSED QUALITY SPECIFICATIONS AT THE TIME OF RELEASE. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ABBOTT REALTIME CMV AMPLIFICATION REAGENT KIT (LIST 05N23-90) LOT 382113 WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE SEARCH DID NOT IDENTIFY ANY RECORDS RELATED TO THE REPORTED ISSUE FOR THESE LOT NUMBERS. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED DISCREPANT RESULTS WHILE USING ABBOTT REALTIME CMV AMPLIFICATION REAGENT KIT (LIST 05N23-90) LOT 382113. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ABBOTT REALTIME CMV AMPLIFICATION REAGENT KIT (LIST 05N23-90) LOT 382113 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A MISQUANTITATION HIGH RESULT ON THE ABBOTT REALTIME CMV AMP KIT. SID (SAMPLE ID) (B)(6), WAS RUN ON (B)(6) 2023, AND GAVE A RESULT OF 2469 IU/ML. THE CLINICAL TEAM QUESTIONED THE RESULT (AS IT WAS A LARGE INCREASE FROM THE PATIENT'S VIRAL LOAD IN COMPARISON TO A FEW DAYS EARLIER). THE SAME PRIMARY TUBE WAS REPEATED ON (B)(6) 2023 AND THE RESULT WAS <62 IU/ML. THE MISQUANTITATION HIGH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CLINICAL MICROBIOLOGIST STATED THAT THERE WAS A POTENTIAL FOR OBSERVED ADVERSE EFFECTS BASED ON THE CHANGE IN MEDICATION. PREVIOUS MEDICATION: VALGANCICLOVIR 500MG BD PO (PROPHYLAXIS) CHANGED MEDICATION: FOSCARNET 4.1 G BD IV (TREATMENT DOSAGE). THE CLINICAL MICROBIOLOGIST STATED THAT BOTH DRUGS HAVE CLEAR TOXICITY, ALTHOUGH FOSCARNET HAS A MORE NARROW, THERAPEUTIC INDEX. ITS PRIMARY TOXICITY IS NEPHROTOXICITY, AND THE MICROBIOLOGIST STATED THAT GIVEN THE PATIENT'S CURRENT CLINICAL STATE, MULTI-ORGAN DYSFUNCTION COULD LEAD TO SUBSTANTIAL DETERIORATION. RENAL FUNCTION AT THE TIME OF INITIATION OF FOSCARNET WAS NORMAL. INTERCURRENT MORBIDITY INCLUDED PNEUMONIA WITH TYPE 1 RESPIRATORY FAILURE WITH PROFOUND NEUTROPENIA. PATIENT WAS AN INPATIENT AT THE TIME OF TESTING/CHANGE TO MANAGEMENT. THE MICROBIOLOGIST REPORTED THAT THE PATIENT'S PRIMARY ILLNESS HAS NOT RECOVERED AS YET ALTHOUGH THEY REMAIN CLINICALLY STABLE. THERE WAS NO ADVERSE REACTION FROM THE ADMINISTRATION OF THE FOSCARNET, ALTHOUGH FURTHER INTERVENTION WAS REQUIRED: ELECTROLYTE AND FLUID REPLACEMENT AND DIURESIS DUE TO EXCESS FLUID ACCUMULATION FROM RENAL PRE-HYDRATION (FOSCARNET); EXTRA ELECTROLYTE MONITORING. BASED ON THE DETAILS OF THE EVENT AND THE MEDICAL ASSESSMENT PROVIDED, THIS EVENT IS BEING RUN AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380103 ABBOTT REALTIME CMV AMPLIFICATION KIT CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY PAB ABBOTT MOLECULAR, INC. 382113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other