MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS

Catalog Number 0006439

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess the instrument test well image in question, which was visually negative.An immucor field service engineer (fse) visited the customer site to assess the testing instrument in question on 20apr2017.The fse found the instrument to be operating as expected.The immucor laboratory tested retention product on 01may2017, which performed as expected.The customer site's full and complete telephone extension (b)(6).

Event Description

On (b)(6) 2017, a (b)(6) customer site reported an unexpected negative antibody screen when using capture-r ready-screen (i and ii) on a galileo neo instrument.

• Brand Name: CAPTURE-R READY-SCREEN (I AND II)
• Type of Device: REAGENT RED BLOOD CELLS
• 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: 6545655
• MDR Text Key: 74639503
• Report Number: 1034569-2017-00088
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234000631
• UDI-Public: 10888234000631
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 102707/0.0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 05/04/2017

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: Medical Technologist
• Device Expiration Date: 05/16/2017
• Device Catalogue Number: 0006439
• Device Lot Number: X463
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/04/2017
• 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: 34 YR