ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
Report
- Report Number
- 1221359-2024-00622
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Date of Event
- September 1, 2024
- Report Date
- October 18, 2024
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QWR
- UDI-DI
- 04571226475447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3: THE DATE OF EVENT IS AN ESTIMATION AS ACTUAL EVENT DATE WAS NOT PROVIDED. D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS. G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J 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 M885159 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 192-000J / LOT: M885159, TEST BASE PART NUMBER 192-430 / LOT: M885159. 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 M885159 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO SAMPLE INTERFERENCE.
B3: THE DATE OF EVENT IS AN ESTIMATION AS ACTUAL EVENT DATE WAS NOT PROVIDED. D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OR UPON RECEIPT OF ADDITIONAL INFORMATION.
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR FIVE (5) PATIENTS PERFORMED ON UNKNOWN DATES. THIS MANUFACTURER REPORT ADDRESSES PATIENT THREE (3) OF FIVE (5). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY (DATE PERFORMED UNKNOWN, BUT RECENTLY). THE PATIENT WAS TESTED WITH THE ASSAY WHICH RETURNED A POSITIVE RESULT. THE CUSTOMER THEN PERFORMED CONFIRMATION TESTING (PCR, DATE PERFORMED UNKNOWN) ON THE PATIENT, WHICH RETURNED A NEGATIVE RESULT. THE PATIENT WAS NOTED TO HAVE NO SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR FIVE (5) PATIENTS PERFORMED ON UNKNOWN DATES. THIS MANUFACTURER REPORT ADDRESSES PATIENT THREE (3) OF FIVE (5). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY (DATE PERFORMED UNKNOWN, BUT RECENTLY). THE PATIENT WAS TESTED WITH THE ASSAY WHICH RETURNED A POSITIVE RESULT. THE CUSTOMER THEN PERFORMED CONFIRMATION TESTING (PCR, DATE PERFORMED UNKNOWN) ON THE PATIENT, WHICH RETURNED A NEGATIVE RESULT. THE PATIENT WAS NOTED TO HAVE NO SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2239559 | ID NOW COVID-19 2.0 TEST KIT 24T JAPAN | SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS | QWR | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | M885159 | 04571226475447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |