MAUDE Adverse Event Report: LIFE TECHNOLOGIES HOLDINGS PTE. LTD. APPLIED BIOSYSTEMS 7500 FAST X REAL-TIME PCR

Catalog Number 4407205

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

A customer reported an overheated plastic smell coming from the instrument, applied biosystems 7500 fast dx (cat.No.# 4407205, serial no.(b)(4)).No pt involvement reported.

Manufacturer Narrative

Device is an instrument and is not implanted/ explanted.The instrument was investigated on site.The complained issue could not be reproduced.While checking the instrument components, a slight discoloration on the lamp cable to the lamp holder connector was observed.It was repaired on site by replacing the lamp holder, lamp cable and lamp.Oq/pv was performed after the repair and the instrument passed required specifications.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.

• Brand Name: APPLIED BIOSYSTEMS 7500 FAST X REAL-TIME PCR
• Manufacturer (Section D): LIFE TECHNOLOGIES HOLDINGS PTE. LTD.; singapore ; SN
• Manufacturer (Section G): LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• Manufacturer Contact: kelli tanzella ; 3175 staley rd.; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3727142
• MDR Text Key: 4325395
• Report Number: 3003673482-2014-00002
• Device Sequence Number: 1
• Product Code: NSU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4407205
• Device Lot Number: 275030204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1