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

Catalog Number 4407205

Device Problem Data Problem (3196)

Patient Problem No Information (3190)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

A customer reported results contained noisy data and spikes in amplification over several cycles after assay run from the instrument, applied biosystems 7500 fast dx (cat.No.4407205, serial no.(b)(4).This resulted in incorrect assay results.No patient involvement reported.(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The instrument investigated on site.The field service engineer (fse) installed new block drive assembly and new camera, a full qualification performed all tests passed, the problem was solved.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 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 PTD. LTD.
• Manufacturer Contact: kelli tanzella ; 3175 staley road, grand island; new york, NY 14072 ; 7167743122
• MDR Report Key: 3978835
• MDR Text Key: 4888856
• Report Number: 3003673482-2014-00036
• 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: 11/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/06/2013
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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