MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORPORATION B17 SSP UNITRAY KIT WITH TAQ POLYMERASE; MZI TEST, QUALITATIVE FOR HLA, NON-D

Catalog Number 472313

Device Problem High Readings (2459)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported in customer complaint #(b)(4) that a survey sample tested when using b locus high res ssp unitray kit (catalog #4730010, lot #009 984375) resulted in b 47:02 when the result should have been b 47:03 (pr# (b)(4)).Catalog #472313 b17 ssp unitray kit with taq polymerase, lot #004 825654 908705 has been identified as product that would be affected by this issue.

Manufacturer Narrative

Internal investigation has confirmed that primer mix b-086 found on lane 9 in the b17 ssp unitray kit with taq polymerase (catalog #472313 lot #004 825654 908705) will give a false negative for the b 47:03 allele in the affected product according to the labeling.The labeling stated the primers in primer mix b-086 would amplify this sequence in the b 47:03 allele.Root cause has been determined to be product design (incorrect labeling).

• Brand Name: B17 SSP UNITRAY KIT WITH TAQ POLYMERASE
• Type of Device: MZI TEST, QUALITATIVE FOR HLA, NON-D
• Manufacturer (Section D): LIFE TECHNOLOGIES CORPORATION; brown deer WI
• Manufacturer Contact: kelli tanzella ; 9099 north deerbrook trail; brown deer, WI 53223 ; 7167743122
• MDR Report Key: 3704992
• MDR Text Key: 4228527
• Report Number: 2244574-2014-00062
• Device Sequence Number: 1
• Product Code: MZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/31/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2012
• Device Catalogue Number: 472313
• Device Lot Number: 004 825654 908705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 006-2012
• Patient Sequence Number: 1