BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 18876700 · Received March 11, 2024

    Report

    Report Number
    1221359-2024-00260
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 7, 2024
    Report Date
    April 9, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. PER THE CUSTOMER, ALL THIRTEEN (13) FALSE POSITIVE RESULTS OCCURRED BETWEEN 07JAN2024 AND 26FEB2024. ALTHOUGH REQUESTED, THE CUSTOMER WAS NOT ABLE TO MATCH WHICH PATIENT TESTED ON WHAT DATE. B5: ALTHOUGH THE CUSTOMER SPECIFIES THIS PROBLEM OCCURRED WITH THIRTEEN (13) PATIENTS ON FOUR (4) AFFECTED LOT NUMBERS, THE CUSTOMER WAS UNABLE TO CLARIFY THE NUMBER OF PATIENT RESULTS THAT WAS ASSOCIATED WITH EACH LOT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. IT IS UNKNOWN HOW MANY FALSE POSITIVES OCCURRED USING EACH LOT. THE INFORMATION AVAILABLE CURRENTLY SPECIFIES THIRTEEN (13) PATIENTS WERE AFFECTED ACROSS FOUR (4) DIFFERENT LOTS: LOT NUMBER: M231845 UDI: (B)(4). EXPIRATION DATE: 1/29/2024 MANUFACTURING DATE: 12/31/2022 LOT NUMBER: M795509 UDI: (B)(4) EXPIRATION DATE: 9/11/2025 MANUFACTURING DATE: 10/13/2023 LOT NUMBER: M796083 UDI: (01)(B)(4) EXPIRATION DATE: 9/12/2025 MANUFACTURING DATE: 10/16/2023 LOT NUMBER: M795498 UDI:(B)(4) EXPIRATION DATE: 9/11/2025 MANUFACTURING DATE: 10/16/2023 THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    B5: ALTHOUGH THE CUSTOMER SPECIFIES THIS PROBLEM OCCURRED WITH TEN (10) PATIENTS ON THREE(3) AFFECTED LOT NUMBERS, THE CUSTOMER WAS UNABLE TO CLARIFY THE NUMBER OF PATIENT RESULTS THAT WAS ASSOCIATED WITH EACH LOT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. IT IS UNKNOWN HOW MANY FALSE POSITIVES OCCURRED ON EACH LOT. THE INFORMATION AVAILABLE CURRENTLY SPECIFIES TEN (10) OR LESS PATIENTS WERE AFFECTED ACROSS THREE (3) DIFFERENT LOTS: LOT NUMBER: M231845; UDI: (B)(4); EXPIRATION DATE: 1/29/2024; MANUFACTURING DATE: 12/31/2022. LOT NUMBER: M795509; UDI: (B)(4); EXPIRATION DATE: 9/11/2025; MANUFACTURING DATE: 10/13/2023; LOT NUMBER: M796083; UDI: (B)(4); EXPIRATION DATE: 9/12/2025; MANUFACTURING DATE: 10/16/2023. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. PER THE CUSTOMER, ALL THIRTEEN (13) FALSE POSITIVE RESULTS OCCURRED BETWEEN (B)(6) 2024 AND (B)(6) 2024. ALTHOUGH REQUESTED, THE CUSTOMER WAS NOT ABLE TO MATCH WHICH PATIENT TESTED ON WHAT DATE. D4-LOT#: ALTHOUGH THE CUSTOMER PROVIDED THE NUMBER OF FALSE RESULTS THAT OCCURRED UNDER EACH LOT, IT IS STILL UNCLEAR WHICH LOT IS ASSOCIATED WITH WHICH PATIENT/FALSE RESULT. D4-UDI: (B)(4) THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M795509 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 193-000/ LOT: M795509, TEST BASE PART NUMBER 192-430/ LOT: M795509. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M795509 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THIRTEEN (13) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ACROSS FOUR (4) DIFFERENT LOTS BETWEEN 07JAN2024 AND 26FEB2024 ON THIRTEEN (13) PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT EIGHT (8). PATIENT EIGHT (8) RECEIVED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY ON AN UNSPECIFIED DATE BETWEEN 07JAN2024 AND 26FEB2024 ON A NASOPHARYNGEAL SAMPLE. CONFIRMATION TESTING WAS PERFORMED ON AN UNKNOWN DATE VIA PCR (PLATFORM: UNKNOWN) WHICH GENERATED A NEGATIVE RESULT ON AN UNKNOWN SAMPLE TYPE. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT RECEIVED ONE DAY OF REMDESIVIR DUE TO THE FALSE RESULT. THE PATIENT WAS HOSPITALIZED FOR TWELVE DAYS. THE REASON FOR THE INITIAL HOSPITALIZATION WAS NOT PROVIDED. THE CUSTOMER INDICATED SOME PATIENTS WERE QUARANTINED WITH OTHER POSITIVE PATIENTS DUE TO THE ID NOW COVID-19 RESULT, HOWEVER, IT IS UNKNOWN IF THIS PATIENT WAS IMPACTED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 WHICH OCCURRED IN TEN (10) OR LESS PATIENTS ACROSS THREE (3) DIFFERENT LOTS ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES PATIENT SIX (6) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW ID NOW COVID-19 ASSAY 2.0 ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM: UNKNOWN) ON AN UNKNOWN DATE WHICH GENERATED NEGATIVE RESULTS. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THIRTEEN (13) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ACROSS FOUR (4) DIFFERENT LOTS BETWEEN (B)(6) 2024 AND (B)(6) 2024 ON THIRTEEN (13) PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT EIGHT (8). PATIENT EIGHT (8) RECEIVED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY ON AN UNSPECIFIED DATE BETWEEN (B)(6) 2024 AND (B)(6) 2024 ON A NASOPHARYNGEAL SAMPLE. CONFIRMATION TESTING WAS PERFORMED ON AN UNKNOWN DATE VIA PCR (PLATFORM: UNKNOWN) WHICH GENERATED A NEGATIVE RESULT ON AN UNKNOWN SAMPLE TYPE. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT RECEIVED ONE DAY OF REMDESIVIR DUE TO THE FALSE RESULT. THE PATIENT WAS HOSPITALIZED FOR TWELVE DAYS. THE REASON FOR THE INITIAL HOSPITALIZATION WAS NOT PROVIDED. THE CUSTOMER INDICATED SOME PATIENTS WERE QUARANTINED WITH OTHER POSITIVE PATIENTS DUE TO THE ID NOW COVID-19 RESULT, HOWEVER, IT IS UNKNOWN IF THIS PATIENT WAS IMPACTED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468878 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M795509

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other| H