MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORP A LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY; MZI TEST, QUALITATIVE FOR HLA, NON-D

Catalog Number 4729110

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Reintubate (2392)

Event Type  malfunction  

Event Description

The customer tested a confirmed ax24:58 sample using a high res ssp unitray kit # 4729010 lot 012 1306793 1417012, but received a result of ax24:02.The lanes positive, 38 and 48, indicate ax24:02 presence, whereas ax24:58 requires lane 56 be positive, which it was not.This result pattern was confirmed in unimatch, however customer gel images were not given.This resulted in a mistype.((b)(4)) a locus high res ssp unitray kit with taq polymerase, cat # 4729110, lot # 012 1306793 1427116 has been identified as having the same issue.

Manufacturer Narrative

A locus high res ssp unitray kit with taq polymerase, cat # 4729110, lot # 012 1306793 1427116 is ongoing.

• Brand Name: A LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY
• Type of Device: MZI TEST, QUALITATIVE FOR HLA, NON-D
• Manufacturer (Section D): LIFE TECHNOLOGIES CORP; 9099 north deerbrook trail; brown deer WI 53223
• Manufacturer (Section G): LIFE TECHNOLOGIES CORP; 9099 north deerbrook trail; brown deer WI 53223
• Manufacturer Contact: kellie tanzella ; 9099 north deerbrook trail; brown deer, WI 53223 ; 7167743122
• MDR Report Key: 3647600
• MDR Text Key: 16058226
• Report Number: 2244574-2014-00035
• Device Sequence Number: 1
• Product Code: MZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 4729110
• Device Lot Number: 012 1306793 1427116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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