ID NOW COVID-19 2.0 TEST KIT 24T OUS
Report
- Report Number
- 1221359-2024-00263
- Event Type
- Malfunction
- Date Received
- March 11, 2024
- Date of Event
- January 7, 2024
- Report Date
- April 9, 2024
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. 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 M231845 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: M231845, TEST BASE PART NUMBER 192-430 / LOT: M231845. 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 M231845 SHOWED THAT THE COMPLAINT RATE IS 0.00198%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.
NEW INFORMATION PROVIDED: A2- AGE SPECIFIED. A3- GENDER SPECIFIED. B3- EVENT OCCURRENCE DATE UPDATED TO REPRESENT THE GIVEN RANGE OF DATES. B5- UPDATED TO INCLUDE SYMPTOMS, IMPACT, AND OUTCOME SPECIFIC TO THAT PATIENT. H6: CODES UPDATED TO REFLECT NEW INFORMATION RECEIVED ON PATIENT IMPACT. 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. 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: (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. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.
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.
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 ON THIRTEEN (13) PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT SIX (6). PATIENT SIX (6) RECEIVED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY ON AN UNSPECIFIED DATE BETWEEN (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 SYMPTOMATIC SEVERAL DAYS PRIOR TO THE COVID-19 TEST. THE PATIENT RECEIVED FIVE DAYS OF LAGEVRIO DUE TO THE FALSE RESULT. PER THE CUSTOMER, THE PATIENT WAS NOT HOSPITALIZED, AS THEY WERE AN OUTPATIENT VISIT ONLY. 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.
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 ON THIRTEEN (13) PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT SIX (6). PATIENT SIX (6) RECEIVED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY ON AN UNSPECIFIED DATE BETWEEN (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 SYMPTOMATIC SEVERAL DAYS PRIOR TO THE COVID-19 TEST. THE PATIENT RECEIVED FIVE DAYS OF LAGEVRIO DUE TO THE FALSE RESULT. PER THE CUSTOMER, THE PATIENT WAS NOT HOSPITALIZED, AS THEY WERE AN OUTPATIENT VISIT ONLY. 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.
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 THREE (3) 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2468877 | ID NOW COVID-19 2.0 TEST KIT 24T OUS | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | M231845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female |