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U.S. Department of Health and Human Services

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

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BIOMERIEUX SA VIDAS HCG VIDAS® HCG Back to Search Results
Catalog Number 30405
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 obtaining out of range high hcg results for two (2) external quality control (instand) samples in association with the vidas® hcg 60 tests (ref 30405, lot 1007736840). Group: 306 , sample 21: expected result sample 21: 47369 (33158 - 61580) u/l. Customer result for sample 21: 68300 u/l. Group: 306 , sample 22: expected result sample 22: 70955 (49669 - 92242) u/l. Customer result for sample 22: 101595 u/l. As these were external quality control samples, there are no patients involved. A biomérieux internal investigation has been initiated. Note: reference 30405 is not registered in the united states. The u. S similar device is product reference 30405-01 (k141133).
 
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Brand NameVIDAS HCG
Type of DeviceVIDAS® HCG
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 Key10907521
MDR Text Key252620321
Report Number8020790-2020-00126
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 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/05/2020
Device Catalogue Number30405
Device Lot Number1007736840
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 Received12/30/2020
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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