MAUDE Adverse Event Report: LIFE TECHNOLOGIES HOLDINGS PTE. LTD. APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR; INSTTRUMENTATION FOR CLINICAL MULTIPL

Catalog Number 4407205

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/12/2012

Event Type  malfunction  

Event Description

A customer reported that the applied biosystems 7500 fast dx real-time pcr instrument (catalog no.4407205 serial no.(b)(4) shows high background in the amplification plot results.We were not made aware of any impact to pt management.(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The field service engineer visually inspected the device and found that the connector and cable plug had burn marks.The fse replaced the lamp cable and controller board.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.

• Brand Name: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
• Type of Device: INSTTRUMENTATION FOR CLINICAL MULTIPL
• Manufacturer (Section D): LIFE TECHNOLOGIES HOLDINGS PTE. LTD.; singapore ; SN
• Manufacturer (Section G): LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• Manufacturer Contact: kelli tanzella ; 3175 staley road; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3978858
• MDR Text Key: 4822222
• Report Number: 3003673482-2014-00026
• 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: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4407205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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