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Adverse Event Report

BAYER CORP. T3 REAGENT IMMUNO 1 TEST OF T3   back to search results
Model Number T01-2949-01
Event Date 03/01/1997
Event Type  Malfunction  
Event Description

In march of 1997 a 80 yr old female presented clinical symptoms of goiter and hyperthyroidism. The pt was treated with thyroid suppressing drugs. It was stated that during the course of this treatment her tsh level rose to and her t4 values decreased to hypothyroid levels. However, her t3 level as measured on the immuno-1 remained elevated (above the normal range). The clinicians continued thyroid suppressing treatment based on the t3 results. It is believed that the pt was mad hypothyroid due to over suppression of her thyroid function.

 
Manufacturer Narrative

The complainant suspected an interference within the pt sample. He performed an ethanol extraction which upon analysis gave a t3 result of 28 ng/dl, which confirmed the hypothyroid condition. These outlier conditions have been explained in paper published in the clinical biochemistry (1995) 28, 55-62 "interference in triiodothyronine (t3) analysis on the immuno 1 analyzer". A study to explore changes to the assay which would minimize such outliers is being conducted. The complaint is considered closed.

 
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Brand NameT3 REAGENT IMMUNO 1
Type of DeviceTEST OF T3
Baseline Brand NameT3 REAGENT IMMUNO 1
Baseline Generic NameTEST FOR T3
Baseline Catalogue NumberT01-2949-01
Baseline Model NumberT01-2949-01
Baseline Device FamilyNA
Baseline Device 510(K) NumberK923258
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed09/28/1992
Manufacturer (Section F)
BAYER CORP.
8365 valley pike po box 307
middletown VA 22645 0307
Manufacturer (Section D)
BAYER CORP.
8365 valley pike po box 307
middletown VA 22645 0307
Manufacturer (Section G)
BAYER HEALTHCARE LLC
555 white plains rd.
5th floor
tarrytown NY 10591
Manufacturer Contact
george tancos
1884 miles ave.
elkhart , IN 46515
(219) 262 -6928
Device Event Key107422
MDR Report Key109291
Event Key102795
Report Number1810909-1997-00011
Device Sequence Number1
Product CodeCDP
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/1998
Device MODEL NumberT01-2949-01
Device Catalogue NumberT01-2949-01
Device LOT NumberT97405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/1996
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Invalid Data

Database last updated on December 31, 2008

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