BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2024-00510
- Event Type
- Malfunction
- Date Received
- July 22, 2024
- Date of Event
- July 12, 2024
- Report Date
- July 30, 2024
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 223145 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 195-160 / LOT 223145, TEST BASE PART NUMBER 195-430H / LOT 220514. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 223145 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE (B)(6) 2024 ON A NASAL SAMPLE WHICH GENERATED POSITIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC (CONGESTION, RUNNY NOSE, COUGH, AND FEVER) ON (B)(6) 2024 AND WAS PRESCRIBED BY HIS DOCTOR TO TAKE ORAL MEDICATION (PERCOCET). HIS DOCTOR DIAGNOSED HIM WITH THE COVID-19 BASED ON HIS RESULT AND ITS SYMPTOMS. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED ON THE (B)(6) 2024 ON A NASAL SAMPLE WHICH GENERATED POSITIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC (CONGESTION, RUNNY NOSE, COUGH, AND FEVER) ON (B)(6) 2024 AND WAS PRESCRIBED BY HIS DOCTOR TO TAKE ORAL MEDICATION (PERCOCET). HIS DOCTOR DIAGNOSED HIM WITH THE COVID-19 BASED ON HIS RESULT AND ITS SYMPTOMS. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736812 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 223145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male |