3500 XL DX GENETIC ANALYZER CS2
Received Mar 27, 2014 · Event occurred Jan 20, 2014
Report 3003673482-2014-00007 · MDR key 3815366
Device
Generic name
Dna Genetic Analyzer
Manufacturer
Life Technologies Holdings Pte. Ltd.Catalog number
4461444
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED THAT THE 3500XL DX GENETIC ANALYZER CS2 (CAT NO 4461444, SERIAL NO (B)(4)) STOPPED IN THE MIDDLE OF AN ASSAY RUN DUE TO THE PRESENCE AIR BUBBLES. NO PATIENT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NUMBER IS (B)(4).
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS INVESTIGATED ON SITE. THE INVESTIGATION DETERMINED THE CAUSE OF THE AIR BUBBLES WAS DUE TO A LEAKING PUMP. THE PUMP WAS REPLACED AND SPATIAL CALIBRATION WAS RUN AFTER THE REPAIR. THE INSTRUMENT PASSED REQUIRED SPATIAL CALIBRATION SPECIFICATIONS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 3500XL DX GENETIC ANALYZER CS2 WITH 3500 DX SERIES SOFTWARE 2011 (VL) ARE IN VITRO DIAGNOSTIC DEVICES INTENDED FOR THE SEQUENCING (DETECTION AND IDENTIFICATION) OF FLUORESCENTLY LABELED DEOXYRIBONUCLEIC ACID (DNA) BY CAPILLARY ELECTROPHORESIS. THE APPLIED BIOSYSTEMS 3500XL DX SEQUENCING ASSAYS SPECIFYING THEIR USE AND ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES, AND USE OF THE ANALYZER.