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

Catalog Number 4407205

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2015 a field service engineer visited the customer site to address the customer complaint of wavy data being reported from the instrument.The field service engineer inspected the instrument and replaced the existing lamp cable with a thicker 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) 2015, a customer submitted a complaint regarding a 7500 fast dx instrument reporting "wavy data." (b)(4).

Manufacturer Narrative

An internal investigation of the complaint found that the issue of "wavy data" caused the affected assay run to fail background calibration.This would cause the run to be completed with no results reported.A historical review of the instrument was conducted.The instrument was installed on june 25, 2012.The replacement of the lamp cable on (b)(6) 2015 was the first instance the lamp cable was replaced.The cause of the replacement was attributed to normal wear and tear of the part.No further investigation is being conducted on the instrument.

Event Description

On (b)(6) 2015, a customer submitted a complaint regarding a 7500 fast dx instrument reporting "wavy data." internal reference# (b)(4).

• 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 staley road; grand island, NY 14072 ; 7167743122
• MDR Report Key: 5359368
• MDR Text Key: 35623005
• Report Number: 3003673482-2016-00001
• Device Sequence Number: 1
• Product Code: NSU
• Combination Product (y/n): N
• 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: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• 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: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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