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

Catalog Number 4407205

Device Problems Device Operates Differently Than Expected (2913); Data Problem (3196)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

On january 20, 2016 a field service engineer visited the customer site to address a customer complaint of wavy data being reported from the instrument.The field service engineer inspected the instrument and replaced the existing lamp cable.After the lamp cable was replaced, the engineer ran performance checks on the instrument.The instrument passed performance check specifications and the customer signed an acknowledgement of the service and repair.

Event Description

On (b)(6) 2016 a customer submitted a complaint regarding a 7500 fast dx instrument having "wavy data issues." (b)(4).

Manufacturer Narrative

A review of the instrument records were conducted as part of the complaint investigation.The instrument was manufactured on october 7, 2007 and installed at the customer site on january 7, 2008.Based on the parts replacement history, the lamp cable replacement performed on (b)(6) 2016 was the first replacement of the lamp cable since the instrument was manufactured.The lamp cable replacement was determined to be part of normal wear and tear of the cable.

• Brand Name: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
• Type of Device: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
• Manufacturer (Section D): LIFE TECHNOLOGIES HOLDINGS PTE LTD.; blk 33, marsiling industrial; estate road 3, no. 07-06; singapore north west, singapore 73925 6; SN 739256
• Manufacturer (Section G): LIFE TECHNOLOGIES HOLDINGS PTE LTD.; blk 33, marsiling industrial; estate road 3, no. 07-06; singapore north west, singapore 73925 6; SN 739256
• Manufacturer Contact: kelli tanzella ; 3175 stanley road; grand island, NY 14072 ; 7167743122
• MDR Report Key: 5445513
• MDR Text Key: 38540044
• Report Number: 3003673482-2016-00002
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4407205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2007
• 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