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

Catalog Number 0066451

Device Problem False Positive Result (1227)

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

Event Date 11/19/2018

Event Type  malfunction  

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 immucor laboratory tested the returned blood sample from the customer site on 20dec2018, against retention product, which yielded the customer's expected negative outcome.The internal immucor number for this report is (b)(4).

Event 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
• 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: 8224272
• MDR Text Key: 133994495
• Report Number: 1034569-2019-00007
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001393
• UDI-Public: 10888234001393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 103497/1014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Expiration Date: 10/02/2019
• Device Catalogue Number: 0066451
• Device Lot Number: 924620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• 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