MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D (SERIES 4) MONOCLONAL BLEND; BLOOD GROUPING REAGENT

Catalog Number	0006412
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on 22aug2018, which performed as expected.The immucor laboratory also received and tested a blood sample on 22aug2018 from the customer site ((b)(4)) and obtained expected negative outcomes.This did not reproduce the customer result outcomes from (b)(6) 2018, but did reproduce the customer result outcomes from more recent blood samples.(b)(4).
Event or Problem Description
On 17aug2018, a customer site reported an unexpectedly positive outcome with anti-d (series 4) monoclonal blend by manual test tube method, when tested on (b)(6) 2018.

• Brand Name: ANTI-D (SERIES 4) MONOCLONAL BLEND
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7860386
• Report Number: 1034569-2018-00201
• Device Sequence Number: 11247784
• Product Code: KSZ
• UDI-Device Identifier: 10888234000556
• UDI-Public: 10888234000556
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: 103523/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: 05/02/2019
• Device Catalogue Number: 0006412
• Device Lot Number: 504768
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR