MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-B (MURINE MONOCLONAL) SERIES 3; BLOOD GROUPING REAGENT

Catalog Number 0006406

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

The immucor laboratory tested retention product on 10oct2018 which performed as expected.(b)(4).

Event Description

On 06oct2018, a customer site reported an unexpectedly positive outcome with anti-b (murine monoclonal) series 3 on a galileo instrument, when tested on (b)(6) 2018.

• Brand Name: ANTI-B (MURINE MONOCLONAL) SERIES 3
• Type of Device: BLOOD GROUPING REAGENT
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 8025577
• MDR Text Key: 125922401
• Report Number: 1034569-2018-00244
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234000532
• UDI-Public: 10888234000532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 102692/1009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 0006406
• Device Lot Number: 203740
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1