APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
Received Jun 27, 2014 · Event occurred Feb 13, 2014
Report 3003673482-2014-00034 · MDR key 3978847
Device
Generic name
Instrumentation For Clinical Multip
Manufacturer
Life Technologies Holdings Pte. Ltd.Catalog number
4407205
Product problems
- Device Sensing Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED THERE WAS SIGNAL DROP OUT IN THE BASELINE, THE INSTRUMENT INVOLVED WAS APPLIED BIOSYSTEMS 7500 FAST DX (CAT NO 4407205, SERIAL NO (B)(4)). NO PT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NO. IS (B)(4).
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS INVESTIGATED ON SITE. IT WAS REPAIRED ON SITE BY REPLACING THE POWER AMP. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE SDS SOFTWARE VERSION 1.4 IS AN 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.