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

Catalog Number 4452300

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

A customer reported a problem of an exceeded maximum hold undershoot coming from veriti dx thermal cycler (cat no.4452300, serial no.(b)(4)).This causes the instrument to stop in the middle of a run.No pt 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 corp and repaired by replacing power amplifier & damper.After repair, the instrument passed all the calibration, final tests, performance specifications.The instrument was sent back to the customer.The device was used as a diagnostic.Device intended use can be found on page 3 other remarks.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 lab techniques and procedures.

• Brand Name: VERITI 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
• Manufacturer Contact: kelli tanzella ; 3175 staley rd; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3855695
• MDR Text Key: 4659058
• Report Number: 3003673482-2014-00008
• 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: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4452300
• Device Lot Number: 299120264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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