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 Problems Contamination (1120); Data Problem (3196)

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

Event Date 03/07/2013

Event Type  malfunction  

Event Description

A (b)(6) field svc engineer reported that contamination from the heated cover of applied biosystems 7500 fast dx real-time pcr instrument (catalog no.4407205 serial no.(b)(4)) caused incorrect results to be reported from a run.We were not made aware of any impact to pt management.The company event tracking no: (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The field svc engineer attributed the contamination issue to wear and tear of the heated cover.The heated cover was replaced and the contamination issue was resolved.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 PTE LTD
• Manufacturer Contact: kelli tanzella ; 3175 staley rd; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3978888
• MDR Text Key: 4822769
• Report Number: 3003673482-2014-00018
• 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: 03/07/2013

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: 03/07/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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