MAUDE Adverse Event Report: LIFE TECHNOLOGIES HOLDINGS PTE. LTD 3500 XL DX GENETIC ANALYZER CS2; PCA

Catalog Number 4461444

Device Problem Failure to Calibrate (2440)

Patient Problem No Information (3190)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

A customer reported there was spatial calibration failure in the instrument, 3500 xl dx genetic analyzer cs2 (cat.No.4461444, serial no.(b)(4)).No patient involvement reported.

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The instrument was investigated on site.It was discovered that the array door was binding, preventing the laser to pass through capillary.The door/spring was disassembled and lubricated.It was then reassembled and installed.Several spatial calibrations were run after the repair and the instrument passed required specifications.Device intended use: the applied biosystems 3500xl dx genetic analyzer cs2 with 3500 dx series software 2011 (vl) are invitro diagnostic devices intended for the sequencing (detection and identification) of fluorescently-labeled deoxyribonucleic acid (dna) by capillary electrophoresis.The applied biosystems 3500xl dx genetic analyzer cs2 with 3500 dx sequencing assays specifying their use and only by technologists trained in laboratory techniques, procedures and use of the analyzer.

• Brand Name: 3500 XL DX GENETIC ANALYZER CS2
• Type of Device: PCA
• 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; grand island, NY 14072 ; 7167743122
• MDR Report Key: 3831934
• MDR Text Key: 4499252
• Report Number: 3003673482-2014-00004
• Device Sequence Number: 1
• Product Code: PCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4461444
• Device Lot Number: 25800-221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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