MAUDE Adverse Event Report: LIFE TECHNOLOGIES HOLDINGS PTE. LTD. VERTI DX THERMAL CYCLER; THERMOCYCLER, GENERIC

Catalog Number 4452300

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

A customer reported an error message "error 0x8007" coming from the instrument, veriti dx thermal cycler (cat no.4452300, serial no.(b)(4)).No patient involvement reported.The company event tracking no.Is (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The instrument was returned to life technologies corporation and repaired by replacing the power amp board.After repair the unit was tested and passed performance specifications.Device intended use: the applied biosystems veriti dx thermal cycler amplifies human nucleic acid samples for diagnostic applications.The veriti dx thermal cycler is to be used only by operators trained in laboratory techniques and procedures.

• Brand Name: VERTI DX THERMAL CYCLER
• Type of Device: THERMOCYCLER, GENERIC
• Manufacturer (Section D): LIFE TECHNOLOGIES HOLDINGS PTE. LTD.; SN
• Manufacturer (Section G): LIFE TECHNOLOGIES HOLDINGS PTE. LTD.; singapore ; SN
• Manufacturer Contact: kelli tanzella ; 3175 staley road; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3949765
• MDR Text Key: 4645605
• Report Number: 3003673482-2014-00010
• Device Sequence Number: 1
• Product Code: OUL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4452300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: Unknown
• Patient Sequence Number: 1