BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12530475 · Received September 24, 2021

    Report

    Report Number
    2023365-2021-00126
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 28, 2021
    Report Date
    September 24, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT LATER REPEATED AS NEGATIVE. THE CUSTOMER ALLEGES THE PLASTIC CONSUMABLE DISC HAD LEAKED AND CAUSED THE FALSE POSITIVES. REQUESTS WERE MADE, BUT RUN FILES WERE NOT PROVIDED FOR ANALYSIS NOR WAS THE LOT INFORMATION FOR THE SIMPLEXA COVID-19 DIRECT ASSAY. THE ONLY INFORMATION PROVIDED WAS A PICTURE OF THE DIRECT AMPLIFICATION DISC KIT MOL1455 LOT# 2021021190. THE MANUFACTURER OF THE DISC LOT, VIANT, OBSERVED NO LEAKAGES DURING THE QC TESTING OF THIS DISC LOT PRIOR TO RELEASE AND INDICATED NOTHING WAS ABNORMAL IN THE TESTING DATA THAT WOULD LEAD TO A POTENTIAL LEAKAGE. RETAINS OF THIS DISC LOT WERE TESTED BY DIASORIN MOLECULAR FOR LEAKAGE AND THE LEAKAGE ISSUE WAS UNCONFIRMED. NO LEAKAGES OCCURRED. A REQUEST FOR RUN FILES AND ASSAY LOT INFORMATION WAS SENT 9/21/21 BUT THE CUSTOMER RESPONDED ON 9/22/21 BY SAYING THEY'VE DECONTAMINATED THEIR INSTRUMENT AND LAB WHILE USING A NEW LOT OF DISCS AND ARE NO LONGER HAVING ISSUES WITH FALSE POSITIVE RESULTS. INVESTIGATION OF THE ASSAY CANNOT PROCEED WITH THE LOT INFORMATION AND THE CUSTOMER DID NOT RETURN THEIR DEVICE OR SUSPECTED FALSE POSITIVE SAMPLES FOR TESTING. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THE SUSPECTED FALSE POSITIVE FROM THE SIMPLEXA COVID-19 DIRECT ASSAY IS CONSIDERED NOT CONFIRMED DUE TO THE LACK OF ASSAY INFORMATION PROVIDED BY THE CUSTOMER AND BY THE RETAIN TESTING PERFORMED ON THE DISC LOT SUSPECTED OF LEAKING THAT WAS UNCONFIRMED.

    Description of Event or Problem · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT LATER REPEATED AS NEGATIVE. THE CUSTOMER ALLEGES THE PLASTIC CONSUMABLE DISC HAD LEAKED AND CAUSED THE FALSE POSITIVES. THE CUSTOMER CONFIRMED THE SUSPECTED FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN OR CLINICIAN. NO ALLEGED HARM OCCURRED. PATIENT HEALTH INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428078 SIMPLEXA COVID-19 DIRECT ASSAY REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA QJR DIASORIN MOLECULAR LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1