ICON MONO RAPID HETEROPHILE ANTIBODY TEST 395100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-23 for ICON MONO RAPID HETEROPHILE ANTIBODY TEST 395100 manufactured by Beckman Coulter, Inc..

Event Text Entries

[1002164] While training a cma to perform a waived icon mono test, the individual was attempting to attach a small black bulb to a glass capillary tube. While pushing the tube into the bulb, the tube broke in the hand of cr. The injury required cr to apply pressure to the wound on the thumb for about 5 minutes. The injury was immediately reported to the manufacturer's representative. A call was received from a customer service representative and a report was placed on file. During the report, the information regarding the discontinued usage of the glass capillary tubes was stated. The company requested that i send them this information, which was forwarded to them. About a month after that, a second injury was incurred by another staff member, hd. Upon further communication was made to the mfr concerning this injury as well. The only recommendation the manufacturer could provide was to purchase a calibrated pipette. This did not seem reasonable since it was a waive test that was being used. The last communication received from the manufacturer was that due to economic conditions there was a hold on any changes in te icon mono kit.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5009403
• MDR Report Key: 1275433
• Date Received: 2008-12-23
• Date of Report: 2008-12-23
• Date of Event: 2008-09-14
• Date Added to Maude: 2009-01-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ICON MONO RAPID HETEROPHILE ANTIBODY TEST
• Generic Name: ICON MONO - WAIVED TEST
• Product Code: KTN
• Date Received: 2008-12-23
• Catalog Number: 395100
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER, INC.
• Manufacturer Address: 4300 HARBOR BLVD FULLERTON CA 92835 US 92835

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-12-23