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

Catalog Number 4407205

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2013

Event Type  malfunction  

Event Description

A customer reported that a fluctuating lamp signal on the instrument applied biosystems 7500 fast dx (catalog no.4407205 with serial no.(b)(4) produced inconsistent data observed through intermittent baseline fluctuations.No pt involvement reported.Company event tracking no: (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Repair was done by replacing lamp, lamp holder and lamp cable.This device is used to obtain results for a diagnosis.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 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 rd; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3978866
• MDR Text Key: 4889402
• Report Number: 3003673482-2014-00019
• 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: Other
• Type of Report: Initial
• Report Date: 06/22/2013

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1