MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORPORATION DRB1*15 SSP UNITRAY KIT WITH TAQ POLYMERASE; MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN

Catalog Number 450112D

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2013

Event Type  malfunction  

Event Description

A discrepancy in typing results using drb1*15 ssp unitray kit (catalog # 450102d, lot 011 1274159) was reported in internal complaint #pr(b)(4).It was discovered that primer mix r15-05c, which is included in lane 5 of drb1*15 ssp unitray kit (catalog #450102d, lot 011 1274159, has been shown to produce a negative reaction in the presence of the drb1*15:34/54/66 alleles.As a result of the negative reaction a sample containing drb1*15:34 allele could mistype as a drb1*16:01:02 and a sample containing drb1*15:54/66 allele could mistype as drb1*15:25.The investigation of internal complaint # (b)(4) identified drb1*15 ssp unitray kit with taq polymerase, catalog # 450112d, lot #011 1049955 1314672 as a product affected by the same issue.

Manufacturer Narrative

An investigation was completed to verify how the primer reactivities assigned within the internal legacy score database were interpreted within the current hos (human oligotyping software) database.The investigation showed there were no other incorrect primer reactivities, however, the investigation identified that some of the primer reactivity assignments were inconsistent between primer mixes.The inconsistency is due to new allelic info being available now, which was not available at the time when the info was initially transferred from the score database to hos database in 2008.Through this investigation, one of the primer reactivities that was identified as needing harmonization had reaction patterns on the date interpretation worksheets and unimatch software that may be interpreted as a potential mis-type assignment for drb1* 15:34 allele as drb1*16:01:02 and drb1* 15:54/66 allele as drb1*15:25.As a product maintenance function, the primer reactivities were updated in the hos database and on the data interpretation worksheets and unimatch software.A customer notification was issued to inform customers of the change to the reactivity patterns shown on the labeling worksheets and unimatch software.

• Type of Device: MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN
• Manufacturer (Section D): LIFE TECHNOLOGIES CORPORATION; brown deer WI
• Manufacturer Contact: kelli tanzella ; 9099 north deerbrook trail; brown deer, WI 53223 ; 7147743122
• MDR Report Key: 3702677
• MDR Text Key: 4263473
• Report Number: 2244574-2014-00015
• Device Sequence Number: 1
• Product Code: IYO
• 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: 10/28/2013

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: 07/31/2013
• Device Catalogue Number: 450112D
• Device Lot Number: 0111049955 1314672
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 013-2013
• Patient Sequence Number: 1