BECKMAN TOTAL THYROXIN REAGENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-29 for BECKMAN TOTAL THYROXIN REAGENT manufactured by Beckman Instruments.

Event Text Entries

[1344100] I am a director of (b)(6), using the beckman access instrument to measure total t4 -tt4- in pts' samples. Twice this year we have received a new lot of tt4 reagent, which resulted in a significant drop in our internal qc results for this test. After much effort to determine the nature of the problem, we conclude that is new reagent. After contacting beckman we are told that, yes, they are/were aware that the new reagent lot is biased from the previous lot. The fda limits for lot-to-lot variation is very wide. Beckman clinical scientists are well aware that most labs internal qc is, by regulatory necessity, tighter than the fda limits for reagent. My complaint is: why doesn't beckman, and other reagent/device companies, provide lot-to-lot variation so as to alert laboratories of a likely bias in their internal qc program. Such an alert would provide data for a qc shift and allow the lab not to waste time investigating a "qc problem".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5016637
• MDR Report Key: 1752534
• Date Received: 2010-06-29
• Date of Report: 2010-06-29
• Date Added to Maude: 2010-07-15
• 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: 0
• 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: BECKMAN TOTAL THYROXIN REAGENT
• Generic Name: ACCESS
• Product Code: KLI
• Date Received: 2010-06-29
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN INSTRUMENTS
• Manufacturer Address: CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-06-29