APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
Received Jun 27, 2014 · Event occurred Nov 6, 2013
Report 3003673482-2014-00036 · MDR key 3978835
Device
Generic name
Instrumentation For Clinical Multip
Manufacturer
Life Technologies Holdings Pte. Ltd.Catalog number
4407205
Product problems
- Data Problem
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT INVESTIGATED ON SITE. THE FIELD SERVICE ENGINEER (FSE) INSTALLED NEW BLOCK DRIVE ASSEMBLY AND NEW CAMERA, A FULL QUALIFICATION PERFORMED ALL TESTS PASSED, THE PROBLEM WAS SOLVED. 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.
Description of Event or Problem
A CUSTOMER REPORTED RESULTS CONTAINED NOISY DATA AND SPIKES IN AMPLIFICATION OVER SEVERAL CYCLES AFTER ASSAY RUN FROM THE INSTRUMENT, APPLIED BIOSYSTEMS 7500 FAST DX (CAT. NO. 4407205, SERIAL NO. (B)(4). THIS RESULTED IN INCORRECT ASSAY RESULTS. NO PATIENT INVOLVEMENT REPORTED. (B)(4).