CLIP COVID RAPID ANTIGEN TEST
Report
- Report Number
- 3015104453-2022-00006
- Event Type
- Malfunction
- Date Received
- May 6, 2022
- Date of Event
- February 10, 2022
- Report Date
- May 5, 2022
- Manufacturer
- LUMINOSTICS (D.B.A. CLIP HEALTH)
- Product Code
- QKP
- UDI-DI
- 10860005391803
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
SYSTEM DESCRIPTION: THE CLIP COVID RAPID ANTIGEN TEST IS A SYSTEM (TEST KIT AND ANALYZER) INDICATED FOR USE IN THE QUALITATIVE DETECTION OF THE NUCLEOCAPSID PROTEIN ANTIGEN FROM SARS-COV-2 DIRECTLY FROM ANTERIOR NASAL SWAB SPECIMENS COLLECTED FROM INDIVIDUALS WHO ARE SUSPECTED OF COVID-19 BY THEIR HEALTHCARE PROVIDER WITHIN THE FIRST FIVE DAYS OF ONSET OF SYMPTOMS. THIS TEST RECEIVED FDA EMERGENCY USE AUTHORIZATION (EUA) AT THE POINT OF CARE (POC), I.E., IN PATIENT CARE SETTINGS OPERATING UNDER A CLIA CERTIFICATE OF WAIVER, CERTIFICATE OF COMPLIANCE, OR CERTIFICATE OF ACCREDITATION. TEST DATA REVIEW: REVIEW OF BATCH RECORDS SHOWS THAT CARTRIDGE LOT CC-10166-A WAS PACKAGED USING NEGATIVE CONTROL SWABS FROM TWO DIFFERENT SWAB LOTS, H21-0120 AND H21-0174. CLIP HEALTH RETAIN SAMPLES OF NEGATIVE CONTROL SWABS FROM BOTH THESE LOTS WERE SUBJECTED TO CONFIRMATION TESTING WITH RETAIN SAMPLES OF CARTRIDGE LOT CC-10166-A. NO FALSE POSITIVES WERE OBSERVED; THE RETAIN PRODUCT IS PERFORMING AS EXPECTED.
SYSTEM DESCRIPTION: THE CLIP COVID RAPID ANTIGEN TEST IS A SYSTEM (TEST KIT AND ANALYZER) INDICATED FOR USE IN THE QUALITATIVE DETECTION OF THE NUCLEOCAPSID PROTEIN ANTIGEN FROM SARS-COV-2 DIRECTLY FROM ANTERIOR NASAL SWAB SPECIMENS COLLECTED FROM INDIVIDUALS WHO ARE SUSPECTED OF COVID-19 BY THEIR HEALTHCARE PROVIDER WITHIN THE FIRST FIVE DAYS OF ONSET OF SYMPTOMS. THIS TEST RECEIVED FDA EMERGENCY USE AUTHORIZATION (EUA) AT THE POINT OF CARE (POC), I.E., IN PATIENT CARE SETTINGS OPERATING UNDER A CLIA CERTIFICATE OF WAIVER, CERTIFICATE OF COMPLIANCE, OR CERTIFICATE OF ACCREDITATION. TEST DATA REVIEW: REVIEW OF BATCH RECORDS SHOWS THAT CARTRIDGE LOT CC-10166-A WAS PACKAGED USING NEGATIVE CONTROL SWABS FROM TWO DIFFERENT SWAB LOTS, H21-0120 AND H21-0174. CLIP HEALTH RETAIN SAMPLES OF NEGATIVE CONTROL SWABS FROM BOTH THESE LOTS WERE SUBJECTED TO CONFIRMATION TESTING WITH RETAIN SAMPLES OF CARTRIDGE LOT CC-10166-A. NO FALSE POSITIVES WERE OBSERVED; THE RETAIN PRODUCT IS PERFORMING AS EXPECTED.
ON THURSDAY, (B)(6), THE CUSTOMER HAD AN ISSUE WITH TWO DIFFERENT ANALYZERS SHOWING A TOTAL OF THREE POSITIVE RESULTS WHEN TESTING NEGATIVE CONTROL SWABS WITH CARTRIDGE LOT CC-10166-A. THE IDENTIFYING INFORMATION IS: ANALYZER CA00506 - SAMPLE ID (B)(6) RUN AT 10:02AM, AND SAMPLE ID (B)(6) RUN AT 11:02AM; AND (2) ANALYZER CA00480 - SAMPLE ID (B)(6) CUSTOMER ALSO USED 2 POSITIVE CONTROL SWABS ON THESE ANALYZERS AND THEY BOTH CAME BACK POSITIVE SAMPLEID: (B)(6).
ON THURSDAY, (B)(6) THE CUSTOMER HAD AN ISSUE WITH TWO DIFFERENT ANALYZERS SHOWING A TOTAL OF THREE POSITIVE RESULTS WHEN TESTING NEGATIVE CONTROL SWABS WITH CARTRIDGE LOT CC-10166-A. THE IDENTIFYING INFORMATION IS: (1) ANALYZER CA00506 - SAMPLE ID (B)(6) RUN AT 10:02AM, AND SAMPLE ID (B)(6) RUN AT 11:02AM; AND (2) ANALYZER CA00480 - SAMPLE ID (B)(6) CUSTOMER ALSO USED 2 POSITIVE CONTROL SWABS ON THESE ANALYZERS AND THEY BOTH CAME BACK POSITIVE SAMPLEID: (B)(6). SAMPLEID:(B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1437454 | CLIP COVID RAPID ANTIGEN TEST | SARS-COV-2 ANTIGEN TEST | QKP | LUMINOSTICS (D.B.A. CLIP HEALTH) | MDL001, CLIP ANALYZER AND MDL002, CLIP COVID RAPID ANTIGEN TEST KIT | CC-10166-A | 10860005391803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |