FDA Adverse Event
Malfunction
Summary report: N
APTIMA SARS COV-2
MDR report key: 14940434
·
Received July 6, 2022
Report
- Report Number
- 2024800-2022-01027
- Event Type
- Malfunction
- Date Received
- July 6, 2022
- Date of Event
- May 24, 2022
- Report Date
- July 6, 2022
- Manufacturer
- HOLOGIC, INC.
- Product Code
- OJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
OTHER.
Description of Event or Problem · 0
CUSTOMER REPORTED ONE SAMPLE TESTED WITH THE SARS-COV-2 ASSAY (ML 319638) ON THE PANTHER INSTRUMENT SN: (B)(4) HAD DISCREPANT RESULTS. INITIAL TEST IS NEGATIVE, AND RETEST IS POSITIVE. THIS WAS A VALIDATION SAMPLE. CUSTOMER USED A KNOWN POSITIVE AND NEGATIVE SAMPLE TESTED WITH THE THERMOFISHER-TAQPACH FOR THE VALIDATION. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS AND NOTED THAT THERE WAS NO INSTRUMENT HARDWARE ERROR OR REAGENT PREPARATION ISSUE. OTHER ASSAY RAN IN THE SAME INSTRUMENT COMPLETED WITHOUT ANY ISSUES. TS CONCLUDED THAT THE ISSUE WAS LIKELY DUE TO A LOW TARGET SAMPLE THAT DID NOT AMPLIFY THREE OF THE FOUR TIMES IT WAS TESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2671099 | APTIMA SARS COV-2 | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | OJR | HOLOGIC, INC. | 319638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |