MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-B ERES SSO TYPING KIT

Catalog Number	628917
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Customer has reported ((b)(4)) to the technical sale specialist on august 2, 2018, during a routine visit that the hla-b allele assignments for sample (b)(6) obtained using lifecodes hla-b eres sso typing kit (lot 01117b), did not agree with the patient first dna sample assignment which was obtained using an alternate vendor's kit back in 2015.The alleles assigned for sample (b)(6) on (b)(6) 2018 were hla-b*57:04 homozygous compared to hla-b*57:04, b*15:01 for the first sample by the alternate vendor's kit back in 2015.The customer indicated as part of their internal investigation, they repeated the sample using the above mentioned lot number and got similar results i.E.Hla-b*57:04 homozygous for sample (b)(6) and hla-b*57:04, b*15:01 heterozygous for the sample.As part of the same internal investigation sample (b)(6)7 was tested using pcr-ssp which gave hla-b*57:04, b*15:01 heterozygous assignment similar to the alternate vendor's assignment back in 2015.Immucor technical support identified that the customer was using the product off label where set up of the assay was using a 1/2 volume protocol.The customer was advised to retest the sample using the standard protocol indicated in the ifu.The customer retested the sample on 01 aug 2018 using the standard protocol indicated in the ifu.The customer obtained the same results on the repeat testing, hla-b*57:04 homozygous when using lifecodes hla-b eres sso typing kit.Immucor technical support reviewed the results sent for the second assay performed and although the run was technically valid, the mfi values of the consensus probes were just above the lowest positive values for the lot (probe 200 = 633.5 & probe 300 = 794) and almost half the values of the consensus probes of the other samples in the run.Dna concentration and purity was confirmed with the customer run and identified the customer was again using 1/2 volumes.A site visit was requested of the customer and the customer declined a visit from immucor field service.Immucor final product quality control records have been reviewed and confirmed that all qc specifications were met for final product and threshold testing.

• Brand Name: LIFECODES HLA-B ERES SSO TYPING KIT
• Common Device Name: LIFECODES HLA-B ERES SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7833214
• Report Number: 2183608-2018-00028
• Device Sequence Number: 1263603
• Product Code: MZI
• UDI-Device Identifier: 10888234400035
• UDI-Public: 10888234400035
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK130075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2018

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: 12/31/2018
• Device Catalogue Number: 628917
• Device Lot Number: 01117B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1