FDA Adverse Event
Malfunction
Summary report: N
BIONOVA
MDR report key: 19504688
·
Received June 10, 2024
Report
- Report Number
- 3013145340-2024-00024
- Event Type
- Malfunction
- Date Received
- June 10, 2024
- Date of Event
- July 31, 2021
- Report Date
- June 10, 2021
- Manufacturer
- TERRAGENE S.A.
- Product Code
- FRC
- UDI-DI
- 07798164676706
- PMA / PMN Number
- K191021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A USER REPORTED THAT INCUBATOR GAVE FALSE NEGATIVE READOUTS FOR POSITIVE CONTROL BIOLOGICAL INDICATORS, INTERNAL TEST REVEALS THAT THERE MAY HAVE BEEN DUST IN THE INDICATOR'S POSITION. NO FURTHER INFORMATION WAS PROVIDED. NO DEVICE-RELATED DEATHS OR SERIOUS INJURIES WERE INFORMED AND THERE IS NO OBJECTIVE EVIDENCE OF PRODUCT MALFUNCTION.
Description of Event or Problem · 0
A USER INFORMED THAT THE AUTO-READER GAVE OUT FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS OR PROCEDURE DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1980926 | BIONOVA | AUTO-READER INCUBATOR | FRC | TERRAGENE S.A. | BIONOVA IC10/20FRLCD | 07798164676706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |