MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. THROMBOTYPE

Catalog Number	THROMBOTYPE
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Thrombotype lot 3005154 (expiration date 08-15-2018) failed to meet testing specifications during 15-month stability testing due to weak and/or absent bands in the hpa-1a and hpa-3a systems during the initial testing on 05/30/2018.The failure mode observed in oos 18-98 was confirmed during repeat testing.Oos 18-98 was initiated to investigate weak and/or absent bands in the hpa-1a and hpa-3a systems during repeat testing on (b)(6) 2018.Alternate samples were tested under oos 18-98, to rule out sample integrity.The replacement samples showed weak/absent bands for hpa-1a and absent bands for hpa-3a.The failures were isolated to the hpa-1a and hpa-3a systems indicating that the other test kit components are performing as expected.This indicates potential degradation of the hpa-1a and hpa-3a primers.A review of similar products in the field identified thrombotype 1 lots 3006502 and 3005160.Thrombotype 1 lot 3005160 was manufactured with the same lots of primer raw materials for the hpa-1a system.The 18 month stability time point was completed on 06/19/2018 and all specifications were met.Therefore, this failure appears to be specific to the manufacture of the thrombotype lot 3005154 primer tubes (primer tube lot 300570).Thrombotype 1 lot 3006502 was manufactured with different lots of primer raw materials for the hpa-1a system.At this time, the root cause is considered to be degradation of the hpa-1a and hpa-3a primers specific to the manufacture of thrombotype primer tube lot 3005070.A review of the thrombotype primer tube lot 3005070 manufacturing records was performed; a specific root cause for the observed failures could not be identified.Further investigation testing into the failure is not able to be performed due to unavailability of adequate kits from thrombotype lot 3005154.Thrombotype lot 3005154 is the only lot of thrombotype currently in the market.

• Brand Name: THROMBOTYPE
• Common Device Name: THROMBOTYPE
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7652289
• Report Number: 2183608-2018-00026
• Device Sequence Number: 125893
• Product Code: MYP
• UDI-Device Identifier: 10888234500285
• UDI-Public: 10888234500285
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK050040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: No Information
• Device Expiration Date: 08/15/2018
• Device Catalogue Number: THROMBOTYPE
• Device Lot Number: 3005154
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1