FDA Adverse Event
Malfunction
Summary report: N
VERIGENE BLOOD CULTURE-GRAM NEGATIVE NUCLEIC ACID TEST KIT
MDR report key: 12856556
·
Received November 22, 2021
Report
- Report Number
- 3006028115-2021-00002
- Event Type
- Malfunction
- Date Received
- November 22, 2021
- Date of Event
- October 27, 2021
- Report Date
- November 22, 2021
- Manufacturer
- LUMINEX CORPORATION
- Product Code
- PEN
- UDI-DI
- 00840487101599
- PMA / PMN Number
- K132843
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A CUSTOMER HAD REPORTED 'NO CALL' INTERNAL CONTROL ERROR ON THREE (3) CARTRIDGES ON THE VERIGENE BC-GN ASSAY. THE 'NO CALL' ERROR HAD OCCURRED DURING QUALITY CONTROL (QC) TESTING, FOR NEGATIVE AND POSITIVE CONTROLS. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT HAD OCCURRED. THERE WAS A DEVICE MALFUNCTION, ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE THE INFORMATION WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1755937 | VERIGENE BLOOD CULTURE-GRAM NEGATIVE NUCLEIC ACID TEST KIT | VERIGENE BC-GN | PEN | LUMINEX CORPORATION | 20-006-021 | 102221021A | 00840487101599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |