MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-K (MONOCLONAL) GAMMA-CLONE; BLOOD GROUPING REAGENT

Catalog Number	0066451
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support use a remote electronic connection method on (b)(4) 2018 to assess the instrument test well images in question, which were visually positive.There were no instrument issues detected.The event log showed no errors.The immucor laboratory tested retention product on 20dec2018, which performed as expected.The internal immucor number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly positive outcome with anti-k (monoclonal) gamma-clone by galileo neo instrument, when tested on (b)(6) 2018.

• Brand Name: ANTI-K (MONOCLONAL) GAMMA-CLONE
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8224115
• Report Number: 1034569-2019-00005
• Device Sequence Number: 264330
• Product Code: KSZ
• UDI-Device Identifier: 10888234001393
• UDI-Public: 10888234001393
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: 103497/1014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: 10/02/2019
• Device Catalogue Number: 0066451
• Device Lot Number: 924620
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1