APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
Received Feb 18, 2016 · Event occurred Jan 20, 2016
Report 3003673482-2016-00002 · MDR key 5445513
Device
Generic name
Applied Biosystems 7500 Fast Dx Real-time Pcr
Manufacturer
Life Technologies Holdings Pte Ltd.Catalog number
4407205
Product problems
- Device Operates Differently Than Expected
- Data Problem
- Device Operates Differently Than Expected
- Data Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE INSTRUMENT RECORDS WERE CONDUCTED AS PART OF THE COMPLAINT INVESTIGATION. THE INSTRUMENT WAS MANUFACTURED ON OCTOBER 7, 2007 AND INSTALLED AT THE CUSTOMER SITE ON JANUARY 7, 2008. BASED ON THE PARTS REPLACEMENT HISTORY, THE LAMP CABLE REPLACEMENT PERFORMED ON (B)(6) 2016 WAS THE FIRST REPLACEMENT OF THE LAMP CABLE SINCE THE INSTRUMENT WAS MANUFACTURED. THE LAMP CABLE REPLACEMENT WAS DETERMINED TO BE PART OF NORMAL WEAR AND TEAR OF THE CABLE.
Additional Manufacturer Narrative
ON JANUARY 20, 2016 A FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO ADDRESS A CUSTOMER COMPLAINT OF WAVY DATA BEING REPORTED FROM THE INSTRUMENT. THE FIELD SERVICE ENGINEER INSPECTED THE INSTRUMENT AND REPLACED THE EXISTING LAMP CABLE. AFTER THE LAMP CABLE WAS REPLACED, THE ENGINEER RAN PERFORMANCE CHECKS ON THE INSTRUMENT. THE INSTRUMENT PASSED PERFORMANCE CHECK SPECIFICATIONS AND THE CUSTOMER SIGNED AN ACKNOWLEDGEMENT OF THE SERVICE AND REPAIR.
Description of Event or Problem
ON (B)(6) 2016 A CUSTOMER SUBMITTED A COMPLAINT REGARDING A 7500 FAST DX INSTRUMENT HAVING "WAVY DATA ISSUES." (B)(4).