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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
Catalog Number 30400
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of falsely underestimated results while testing external quality control samples (biorad level 1 and level 2 controls) with the vidas® tsh 60 tests (ref 30400, lot 1007944790). Level 1 (lot 40361): target value of biorad: 0. 38 miu/l. Rilibäk range: 0. 38 miu/l +/- 13. 5 %
=
0. 33 ¿ 0. 43 miu/l. The customer must conform to the rilibäk range. Customer results of level 1: 0. 3 miu/l
=
invalid. Level 2 (lot 40362): target value of biorad: 37 miu/l. Rilibäk range: 37 miu/l +/- 13. 5 %
=
33 - 43 miu/l. The customer must conform to the rilibäk range. Customer results of level 2: 30. 75 miu/l
=
invalid. As testing was performed on external quality control samples, there are no patients involved. Note: reference 30400 is not registered in the united states. The u. S similar device is product reference 30400-01 (k141133). A biomérieux internal investigation has been initiated.
 
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Brand NameVIDAS TSH
Type of DeviceVIDAS® TSH
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile 69280
FR 69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile 69280
FR 69280
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10906590
MDR Text Key254788822
Report Number8020790-2020-00124
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K141133
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2021
Device Catalogue Number30400
Device Lot Number1007944790
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 Received11/27/2020
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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