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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS FSH 60 TESTS VIDAS® FSH 60 TESTS

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BIOMERIEUX SA VIDAS FSH 60 TESTS VIDAS® FSH 60 TESTS Back to Search Results
Catalog Number 30407
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Note: reference (b)(4) is not registered in the united states. The u. S. Similar device is product reference (b)(4). A customer in (b)(6) notified biomérieux of obtaining an out range result for an external instand quality control sample in association with the vidas® fsh 60 tests (ref (b)(4), batch 1007652290). The customer stated out of range low result was obtained when testing instand quality control sample 22. Customer result and specified range are listed below. Sample 22, customer result: 55. 1 iu/l, specified range: 55. 7 ¿ 85. 3 iu/i. As there is no patient associated with this quality control sample, there is no adverse event related to any patient's state of health. Biomérieux has initiated an internal investigation.
 
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Brand NameVIDAS FSH 60 TESTS
Type of DeviceVIDAS® FSH 60 TESTS
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
jeff scanlan
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key10402471
MDR Text Key205489093
Report Number8020790-2020-00076
Device Sequence Number1
Product Code CGJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K921746
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 09/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2020
Device Catalogue Number30407
Device Lot Number1007652290
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 Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2019
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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