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

Catalog Number 303469

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

Patient Problem No Information (3190)

Event Date 01/05/2018

Event Type  malfunction  

Event Description

Customer complaint ((b)(4)) was received 09 jan 2018.On (b)(6) 2017, customer tested fresh patient sample with lot 3005747 of pakplus and received a negative result for well a.Customer received new lot of pakplus 3006225 on (b)(6) 2018.On (b)(6) 2018, customer testing with lot 3006225 of pakplus on a patient aliquot from (b)(6) 2017.The result for well a was positive.Customer also tested another patient aliquot collected from (b)(6) with lot 3005747 and well a was negative.Testing was repeated on (b)(6) 2018 using both lots.Lot 3005747 resulted in well a negative and lot 3006225 resulted in well a positive.Customer reported negative results on the patient from the initial testing.

• Brand Name: PAKPLUS
• Type of Device: PAKPLUS
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53816
• Manufacturer (Section G): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer Contact: stephen conran ; 20925 crossroads circle; waukesha, WI 53186 ; 2627541016
• MDR Report Key: 7257347
• MDR Text Key: 99992162
• Report Number: 2183608-2018-00003
• Device Sequence Number: 1
• Product Code: MYP
• UDI-Device Identifier: 10888234500254
• UDI-Public: 10888234500254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/15/2018
• Device Catalogue Number: 303469
• Device Lot Number: 3006225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2018
• 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