FDA Adverse Event
Malfunction
Summary report: N
VERITI DX THERMAL CYCLER
MDR report key: 3672886
·
Received January 15, 2014
Report
- Report Number
- 3003673482-2014-00001
- Event Type
- Malfunction
- Date Received
- January 15, 2014
- Date of Event
- December 12, 2013
- Report Date
- December 12, 2013
- Manufacturer
- LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- Product Code
- NSU
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS VERITI DX THERMAL CYCLER AMPLIFIES HUMAN NUCLEIC ACID SAMPLES FOR DIAGNOSTIC APPLICATIONS. THE VERITI DX THERMAL CYCLER IS TO BE USED ONLY BY OPERATORS TRAINED IN LAB TECHNIQUES AND PROCEDURES. THE INSTRUMENT WAS REPAIRED BY REPLACING THE PCA CONTROLLER BOARD. THIS IS THE INITIAL AND FINAL REPORT FOR THIS ISSUE.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE INSTRUMENT VERITI DX THERMAL CYCLER (CAT # 4452300, SERIAL # (B)(4)) HAD PCA CONTROLLER BOARD PROBLEM. NO PT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39303 | VERITI DX THERMAL CYCLER | THERMOCYCLER, GENERIC | NSU | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | 299120182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |