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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 that they observed out of range high results when using vidas® hcg 60 tests (ref. 30405, lot 1008107910), in the context of an external quality control. As this was an external quality control sample, there is no patient involved. The customer obtained the following results when testing the liquichek immunoassay plus control bio-rad, level 1 with vidas hcg 60 tests, lot 1008107910: on (b)(6) 2020: 5. 39 mui/ml. On (b)(6) 2020: 5. 55 mui/ml, 6. 29 mui/ml, 6. 07 mui/ml, 5. 35 mui/ml, 6. 02 mui/ml. On (b)(6) 2020: 5. 13 mui/ml. The expected range for this qc sample level 1 was 4. 23 (3. 51 - 4. 949) rilibäk range (17% deviation). It is reported that calibrations performed on (b)(6) 2020 and on (b)(6) 2020 were valid. 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
matthew locus
595 anglum road
hazelwood, MO 63042
MDR Report Key10907491
MDR Text Key252878013
Report Number8020790-2020-00127
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
Report Date 11/25/2020
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 Date05/20/2021
Device Catalogue Number30405
Device Lot Number1008107910
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 Received10/30/2020
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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