D
Patient 1
A CUSTOMER REPORTED THAT THE HEATED COVER OF INSTRUMENT APPLIED BIOSYSTEMS 7500 FAST DX (CAT. NO. 4407205) WITH SERIAL NO. (B)(4) WAS NOT HEATING. NO PATIENT INVOLVEMENT REPORTED.
MAUDE MDR 3624215
- MDR report key
- 3624215
- Report number
- 3003673482-2013-00039
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-03-01
- Date received
- 2013-12-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KELLI TANZELLA
- Address
- 3175 STALEY RD. GRAND ISLAND NEW YORK NY 14072 US
- Phone
- 716-716-7167
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR | NSU 862.2570 | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | NSU | 4407205 | 275011324 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-12-09 | 0 |
Event Narratives#
N
Patient 1
DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE SDS SOFTWARE VERSION 1.4 IS A REAL-TIME NUCLEIC ACID AMPLIFICATION AND DETECTION SYSTEM THAT MEASURES NUCLEIC ACID SIGNALS FROM REVERSE TRANSCRIBED RNA AND CONVERTS THEM TO COMPARATIVE QUANTITATIVE READOUTS USING FLUORESCENT DETECTION OF DUAL-LABELED HYDROLYSIS PROBES. THE 7500 FAST DX REAL-TIME PCR INSTRUMENT IS TO BE USED ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES, AND ON USE OF THE ANALYZER. THE INSTRUMENT WAS REPAIRED BY REPLACING HEATED COVER. THIS IS THE INITIAL AND FINAL REPORT FOR THIS ISSUE.