MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. THROMBOTYPE 1 ASSAY

Catalog Number 303479

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2017

Event Type  malfunction  

Event Description

A complaint ((b)(4)) was received on 10 august 2017 for thrombotype 1, lot 3004507.The customer ((b)(6)) contacted immucor on 10 august 2017 regarding failed runs.On 11 august 2017, the customer informed immucor that they were having intermittent technical issues over the last several months.The customer had only one successful run, out of four attempts, in the two weeks prior to the complaint.In the testing gels provided by the customer, the internal control bands can be clearly seen, but the are no genetic bands for either the a or b reaction.There are a few samples where there is a partial band, but nothing significant enough to allow a determination they were experiencing low reactivity, even the banding with the controls was deemed inadequate.

Event Description

(b)(6) follow-up 2 to correct date of event and date of report.

Event Description

Refer to initial report submitted on 09/08/2017.12/29/2020 ab: notification from fda was received on november 27, 2020 notifying immucor gti diagnostics that this follow-up 1 report was not received but a follow-up 2 was.Submission of this report is being provided per direction received.

• Brand Name: THROMBOTYPE 1 ASSAY
• Type of Device: THROMBOTYPE 1 ASSAY
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer (Section G): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer Contact: joan rixe ; 20925 crossroads circle; waukesha, WI 53186 ; 2627541016
• MDR Report Key: 6853525
• MDR Text Key: 86009617
• Report Number: 2183608-2017-00004
• Device Sequence Number: 1
• Product Code: MYP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/15/2018
• Device Catalogue Number: 303479
• Device Lot Number: 3004507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1