MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. DONORSCREEN-HLA CLASS I AND CLASS II; TEST, HLA

Catalog Number	DSI+II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
User laboratory notified immucor gti diagnostics that they used components from 2 lots of product during 3 testing runs.The mistake was identified during the third run which was aborted.The samples from this third run were repeated using kit components from one lot of product.The two prior runs, samples which resulted as positive were regarded as such and the blood products which the testing was performed on were discarded.Samples which originally resulted as negative were repeated using components from one lot of product.One sample which originally resulted as negative in turn resulted as positive.The blood product which the sample was from was able to be 'recalled' and it was destroyed.Immucor complaint number for report by customer was (b)(4).No patient harm occurred.Regulatory reporting was not performed at the time of the event.This event was categorized as not requiring mdr reporting.A review of potential events during 2017 was performed in january 2018.At that time, it was identified that due to this being user incorrect performance of an assay leading to a false negative result, an mdr would be submitted.The product lots used were: 3004096a and 3004609a.The date of the event as experienced by the user laboratory is unknown.

• Brand Name: DONORSCREEN-HLA CLASS I AND CLASS II
• Common Device Name: TEST, HLA
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7542131
• Report Number: 2183608-2018-00009
• Device Sequence Number: 11145057
• Product Code: MZI
• UDI-Device Identifier: 10888234500193
• UDI-Public: 10888234500193
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK070045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

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: Medical Technologist
• Device Expiration Date: 03/15/2018
• Device Catalogue Number: DSI+II
• Device Lot Number: 3004096A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other