ANTI-FY (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST 725230 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-29 for ANTI-FY (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST 725230 NA manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[18548763] False negative reaction was reported with anti-fy (anti-duffy) for indirect antiglobulin test. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2250051-2003-01028
• MDR Report Key: 475126
• Date Received: 2003-07-29
• Date of Report: 2003-07-26
• Date of Event: 2003-04-17
• Date Facility Aware: 2003-05-12
• Report Date: 2003-07-26
• Date Added to Maude: 2003-08-04
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ANTI-FY (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST
• Generic Name: REAGENT ANTISERA
• Product Code: LSE
• Date Received: 2003-07-29
• Model Number: 725230
• Catalog Number: NA
• Lot Number: FYB53A
• ID Number: NA
• Device Expiration Date: 2003-09-04
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 463996
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 1001 US HWY 202 RARITAN NJ 088690606 US
• Baseline Brand Name: ANTI-FYB (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST
• Baseline Generic Name: BLOOD GROUPING REAGENTS
• Baseline Model No: NA
• Baseline Catalog No: 725230
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 15
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-07-29