BEUDAMED
    FDA Adverse Event Death Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12697034 · Received October 26, 2021

    Report

    Report Number
    1221359-2021-03094
    Event Type
    Death
    Date Received
    October 26, 2021
    Date of Event
    August 20, 2021
    Report Date
    December 16, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER IDENTIFIED THE CONFIRMATORY TESTING WAS CONDUCTED BY A PUBLIC HEALTH CENTER ((B)(6) HEALTH CENTER) THE SAME DAY AS THE ID NOW TEST. IT WAS ALSO CLARIFIED THAT THE CUSTOMER USUALLY RECEIVES THE CONFIRMATORY PCR TESTING RESULT IN 2 DAYS; HOWEVER, THE CUSTOMER CANNOT CONFIRM THE EXACT DATE OF RECEIPT. IT WAS ALSO REPORTED THE PATIENT PRESENTED TO THE (B)(6) CLINIC ON (B)(6) 2021 WITH "ROUGH" BREATHING, AN SPO2 OF "ABOUT 85-96%" AND A "FEELING OF COLD ON FINGERS". THE NEXT DAY, A "SHARP" DETERIORATION OF 75- 90%" WAS SEEN AND OXYGEN THERAPY WAS SOON PROVIDED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 "AROUND 11AM TO NOON". PER THE CUSTOMER, THERE IS NO DETAILED INFORMATION REGARDING THE MICROBIOLOGIC CAUSE OF THE PATIENT'S PNEUMONIA AND THAT PER THE CT SCAN, MOST OF THE RIGHT LUNG HAD FROSTED GLASS-LIKE CHANGES AND THE LEFT LUNG ALSO HAD A SHADOW. THE PATIENT WAS TREATED WITH STEROIDAL PULSE THERAPY, ANTIBACTERIAL DRUG INFUSION AND OXYGEN THERAPY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CLARIFIED THE HOSPITAL WAS UNDER A STATE OF EMERGENCY. THIS CLINIC PROVIDES ID NOW COVID-19 TESTING AND IS ALLOWED TO REFUSE TREATMENT OR HOSPITALIZATION FOR COVID-19 POSITIVE PATIENTS. PATIENTS WILL BE TREATED AT A NEARBY INFECTIOUS DISEASE DESIGNATED MEDICAL INSTITUTION OR HOSPITALIZATION COOPERATION MEDICAL INSTITUTION. A SUMMARY OF THE INVESTIGATION FINDINGS ARE SUMMARIZED BELOW: THE CUSTOMER REPORTED FALSE POSITIVE PATIENT RESULTS WITH THE ID NOW COVID-19 ASSAY DURING ROUTINE PATIENT TESTING OF NASOPHARYNGEAL SAMPLES THAT WERE COLLECTED USING UNKNOWN SWABS AND TESTED DIRECTLY IMMEDIATELY AFTER COLLECTION. CONFIRMATION TESTING WAS PERFORMED USING PCR (UNKNOWN MANUFACTURER). WE WERE UNABLE TO CONFIRM DETAILS OF CONFIRMATION TESTING; THE DATES AND TIMES OF THE REPEAT TEST RESULTS; AND ANY ADDITIONAL INFORMATION REGARDING THE PATIENTS (INCLUDING THE INFORMATION REQUIRED FOR VIGILANCE REPORTING). A REVIEW OF THE MANUFACTURING AND QUALITY CONTROL RELEASE TESTING FOR TEST BASE LOT M159043. CONCLUDED THAT THE LOT MET RELEASE SPECIFICATIONS. RETAIN KITS FOR THIS LOT WERE WAS TESTED WITH ABBOTT DIAGNOSTICS SCARBOROUGH'S LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X2 DEVICES AND NEGATIVE CONTROL SWABS X2 DEVICES. ALL TESTS PERFORMED AS EXPECTED WITH NO FALSE POSITIVE RESULTS OBSERVED. THE CURRENT OVERALL PERCENTAGE OF FALSE POSITIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED, AND CONFLICTING), BASED ON THE TOTAL NUMBER OF DEVICES SOLD AND THE EVIDENCE AVAILABLE, WAS 0.005% FOR LOT M159043, WHICH INDICATED THAT LOT M15904 IS PERFORMING AS EXPECTED. THE LOG FILES SUBMITTED TO ABBOTT DIAGNOSTICS SCARBOROUGH WERE REVIEWED FOR ID NOW COVID-19 FALSE POSITIVES FOR THE TEST DATE OF (B)(6) 2021 AND LOGFILES SHOWED THAT VALID POSITIVE TEST RESULTS WERE GENERATED ON THAT DATE, AND NO ERRORS OR ISSUES WERE OBSERVED IN THE LOG FILE. IN CONCLUSION, THE BATCH RECORD REVIEW, RETAIN KIT TESTING, COMPLAINT TRENDING, AND INSTRUMENT LOG REVIEW CONCLUDED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE AND NO PRODUCT ISSUE WAS IDENTIFIED. TAKING INTO CONSIDERATION THE INFORMATION IN THE COMPLAINT CASE REGARDING THE PATIENT'S PRESENTING SYMPTOMS, THE LIMITED INFORMATION AVAILABLE FROM THE HOSPITAL'S CONFIRMATORY TESTING, AS WELL AS THE BATCH RECORD, LOG FILE REVIEWS AND RETAIN TESTING CONDUCTED AS PART OF THE COMPLAINT INVESTIGATION, ABBOTT DIAGNOSTICS SCARBOROUGH HAS NOT IDENTIFIED ANY RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE KNOWN PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, A MEDICAL OPINION IS PENDING TO DETERMINE THE RELATION OF THIS DEVICE TO THE REPORTED PHENOMENON. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. THE CUSTOMER ALSO REPORTED THAT THREE PATIENTS RECEIVED FALSE POSITIVE RESULTS PLEASE REFERENCE MFR. REPORT NUMBERS: 1221359-2021-03308 ((B)(6) 2021), 1221359-2021-03309 ((B)(6) 2021) AND 1221359-2021-03310 ((B)(6) 2021).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL SWAB. THE CUSTOMER REPORTED THAT THE PATIENT'S ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 GENERATED A POSITIVE RESULT. PCR CONFIRMATION TESTING PERFORMED ON GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE PCR TEST RESULT TOOK TWO DAYS DUE TO THE HIGHEST NUMBERS OF COVID19 POSITIVE PATIENT IN (B)(6) AT THAT TIME. THE CUSTOMER REQUESTED TO CONDUCT THE PCR TEST OUTSIDE OF THEIR FACILITY AS THIS FACILITY WAS OVERWHELMED. THE CUSTOMER REPORTED THAT THE PATIENT WAS ELDERLY AND SYMPTOMATIC WITH PNEUMONIA. THE PATIENT HAD BEEN TESTED FOR COVID AS PART OF THE FACILITY'S PRE-ADMISSION PROCESS. THE CUSTOMER REPORTED THAT THE FACILITY WAS UNABLE TO ACCEPT AND HOSPITALIZE THE PATIENT DUE TO CONCERN OF COVID INFECTION AND THE CUSTOMER HAD TO SEND THE PATIENT BACK TO HIS HOME. IN ADDITION, THE CUSTOMER REPORTED THAT THE FACILITY WAS UNABLE TO FIND ANOTHER FACILITY WHO COULD ACCEPT THIS PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT'S HOSPITALIZATION WAS DELAYED FOR AN UNSPECIFIED PERIOD OF TIME WHILE WAITING FOR THE PCR RESULTS. ACCORDING TO THE CUSTOMER, THE PATIENT WAS HOSPITALIZED AFTER HIS RESPIRATORY CONDITION DETERIORATED AND EXPIRED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594120 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M159043 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death