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

Catalog Number 0066813

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019, immucor performed c antigen testing by tube method using 4 heterozygous (c+c+) and 4 c negative cells from 2 retention panocell-20 products, lots 09577 and 12616, and retention anti-c monoclonal gamma-clone lot 936180.All c+c+ cells resulted positive as expected, and all c-c+ cells resulted negative as expected.Retention lot 936180 performed as expected.A sample of patient whole blood was obtained from the site and sent to immucor dx for rhd and rhce genotyping.The sample was genotyped on (b)(6) 2019 with the following results: from the rhce analysis, the genotype is c-, c+, e-, e+.Patient has a variant: ceti/ceti (homozygous ceti).This is a mutation in the rh gene that causes expression of a partial c antigen and a partial e antigen.This patient will be able to develop anti-c and anti-e antibodies if exposed to those antigens via transfusion.From the rhd analysis, the genotype was found to be diva type 2 or diva type 2/diiia-ce(4-7)-d.Patient is phenotypically partial d, which is expressed as an altered form of the d antigen and is likely to form an anti-d if exposed to the d antigen via transfusion.According to immucor dx, this is not surprising since these two variants tend to be seen together.Immucor dx also stated that this genotype is notoriously difficult to type serologically and will almost always give discrepant results.Per immucor dx, this patient should essentially be treated as negative for all of the rh antigens (d, c, c, e, and e).The immucor internal report record number for this report is (b)(4).

Event Description

On (b)(6) 2019 a customer reported unexpected positive results with gamma-clone anti-c (monoclonal).

• Brand Name: GAMMA-CLONE ANTI-C (MONOCLONAL)
• Type of Device: ANTI-C 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: 8609433
• MDR Text Key: 162081936
• Report Number: 1034569-2019-00095
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001355
• UDI-Public: 10888234001355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL103498
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/21/2019
• Device Catalogue Number: 0066813
• Device Lot Number: 936180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 5 YR