MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA DQAB

Model Number	3006951
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample (b)(6): discordant dqa.Ssp results: dqa1*01:03 dqa1*02:01.Lifecodes sso result: dqa1*01:xx dqa1*01:xx.Probe 207 assignment (52% below cut-off) would have to be changed to positive for result to be concordant with ssp.Batch shows no evidence of contamination.Customer also reports incorrect sso result with sample (b)(6).Raw data requested.Laboratory visit confirms that all testing is performed according to instructions listed in ifu for product.And customer is using verity cycler for amplification and hybridization steps of protocol.Laboratory visit confirms that match it dna software has (b)(6) database applied.Sso results for dqab for these samples were not reported.
Event or Problem Description
Customer reports incorrect result with samples tested with lifecodes dqab sso lot 3006951.Customer reports 2 samples gave results discordant with ssp sample (b)(6): discordant dqa.Ssp results: dqa1*01:03 dqa1*02:01.Lifecodes sso result: dqa1*01:xx dqa1*01:xx.Probe 207 assignment (52% below cut-off) would have to be changed to positive for result to be concordant with ssp.Batch shows no evidence of contamination.Customer also reports incorrect sso result with sample (b)(6).Raw data requested.Laboratory visit confirms that all testing is performed according to instructions listed in ifu for product.And customer is using verity cycler for amplification and hybridization steps of protocol.Laboratory visit confirms that match it dna software has (b)(6) database applied.Sso results for dqab for these samples were not reported.
Event or Problem Description
Customer reports incorrect result with samples tested with lifecodes dqab sso lot 3006951.Customer reports 2 samples gave results discordant with ssp sample 18-1203: discordant dqa.Ssp results: dqa1*01:03 dqa1*02:01.Lifecodes sso result: dqa1*01:xx dqa1*01:xx.Probe 207 assignment (52% below cut-off) would have to be changed to positive for result to be concordant with ssp.Batch shows no evidence of contamination.Customer also reports incorrect sso result with sample (b)(4).Raw data requested.Laboratory visit confirms that all testing is performed according to instructions listed in ifu for product.And customer is using verity cycler for amplification and hybridization steps of protocol.Laboratory visit confirms that match it dna software has imgt 3.33 database applied.Sso results for dqab for these samples were not reported.Csv files and ssp documents attached.
Additional Manufacturer Narrative
Smp #1 the sample confirmed issue.28feb2019 (b)(6).Samples received and internal testing completed.Sample 18-1203: testing with lifecodes hla dqab sso gave hla dqa typing dqa1*01:xx dqb1*01:xx.In order for results to be concordant with ssp (dqa1*01:03 dqa1*02:01) probe 207 should be assigned as pos.Probe 207 assigned as negative with adjust value falling at 18% and 24 % below lot-specific cut-off in respective replicates.Customer observation was reproduced.Smp #2 the sample did not confirm and tested concordant 28feb2019 (b)(6).Samples received and internal testing completed.Sample 18-1174: testing with lifecodes hla dqab sso gave hla dqb typing dqb1*03:xx dqb1*05:xx.This result is concordant with result obtained by customer with ssp testing.Probes 242, 274, 281, and 292 were all assigned as positive and greater than 30% from lot specific cut-offs in both replicates.Customer observation was not reproduced.

• Brand Name: LIFECODES HLA DQAB
• Common Device Name: HLA DQAB
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 8373640
• Report Number: 2183608-2019-00001
• Device Sequence Number: 13899067
• Product Code: MZI
• UDI-Device Identifier: 10888234400462
• UDI-Public: 10888234400462
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK150302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2019
• Device Model Number: 3006951
• Device Catalogue Number: 200210-50
• Device Lot Number: 3006951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1