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

Catalog Number 4406985

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

A customer reported a heater block issue on the instrument applied biosystems 7500 fast dx (catalog no.4406985) with serial no.(b)(4), resulting in incorrect results from an assay run.No pt involvement reported.(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The repair was completed by replacing the sample block.The instrument passed all specification tests after the sample block was replaced.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 REAK TIME PCR
• Type of Device: INSRUMENTATION 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: 3978887
• MDR Text Key: 18064203
• Report Number: 3003673482-2014-00020
• 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: 01/16/2014

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: 4406985
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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