MAUDE Adverse Event Report: LIFE TECHNOLOGIES HOLDINGS PTE LTD APPLIED BIIOSYSTEMS 7500 FAST DX REAL-TIME PCR; INSTRUMENTATION FOR CLINICAL MULTIP

Catalog Number 4407205

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/19/2013

Event Type  malfunction  

Event Description

A customer reported poor data obtained from a run using the applied biosystems 7500 fast dx real-time pcr instrument (catalog no.4407205 serial no.(b)(4)).Data was wavy and had large gaps in amplification plot.No pt involvement was reported.The company event tracking no: (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The instrument was investigated on site.The root cause was determined to be a software design issue which prevented the customer from obtaining results after a run.To by-pass the software issue, the field application specialist instructed the customer on how to use the "import from file" function in the software.This allowed the customer to obtain results after the run.The software issue has been addressed and a new version of the software is scheduled for release.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 BIIOSYSTEMS 7500 FAST DX REAL-TIME PCR
• Type of Device: INSTRUMENTATION FOR CLINICAL MULTIP
• 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: 3978867
• MDR Text Key: 4823344
• Report Number: 3003673482-2014-00017
• 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: 04/19/2013

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: 04/19/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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