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

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

Event Date 04/24/2013

Event Type  malfunction  

Event Description

A customer reported noisy amplification plot and component plot on the instrument applied biosystem 7500 fast dx (cat no.4407205) with serial no.(b)(4), resulting in incorrect, wavy results.No pt involvement reported.Company event tracking no.(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Repair completed by changing the lamp and performing optical alignment and re-optical calibration.The repaired instrument passed all specifications.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 an 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 road; estate road 3, # 05-03; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3978856
• MDR Text Key: 4822221
• Report Number: 3003673482-2014-00027
• 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: 04/24/2013

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: 04/24/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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