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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS TSH VIDAS® TSH

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BIOMERIEUX SA VIDAS TSH VIDAS® TSH Back to Search Results
Model Number 30400-01
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux that they have observed falsely low results for a patient's sample in association with the vidas® tsh 60 tests (ref. #: (b)(4), lot #:1007944800) compared to results obtained by an external laboratory. The customer stated that they had tested a patient tsh sample on their vidas, the results were as follows: patient 1: vidas result
=
0. 08 (units not reported). Repeat analysis with the vidas tsh obtained the same results. The sample was then sent to an external laboratory for reference testing as the customer indicated that the vidas results did not match the last time the tsh was ran for the patient. The external laboratory results were as follows: patient 1: labcorp result
=
4. 08 (units not reported). The customer was unsure, which test method was used by the external laboratory. The customer reported that no incorrect results were reported to the treating physician, there was no delay in reporting results, and this event did not lead to any adverse event related to the patient's state of health. A biomérieux internal investigation will be initiated.
 
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Brand NameVIDAS TSH
Type of DeviceVIDAS® TSH
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
69280
FR 69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile 69280
FR 69280
Manufacturer Contact
jennifer armstrong
595 anglum road
hazelwood, MO 63042
MDR Report Key11032295
MDR Text Key241258535
Report Number8020790-2020-00139
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141133
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2021
Device Model Number30400-01
Device Catalogue Number30400-01
Device Lot Number1007944800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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