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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, INC INCUBATOR MOD LEFT W/RACKS 3D

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BIOMÉRIEUX, INC INCUBATOR MOD LEFT W/RACKS 3D Back to Search Results
Model Number 210159
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
An industry customer in the united states notified biomerieux of a false positive result in association with their bact/alert® incubator mod left w/racks 3d (ref. 210159, serial # (b)(4)) when testing advanced therapy medical product (atmp). The customer stated two (2) ifa plus culture bottles were declared positive; however, when reviewing the bottle graphs the growth curves were flat. One (1) bottle was sub-cultured and gram-stained. The customer stated they may have observed gram-positive cocci; however, this was unconfirmed as no organisms were present on the gram slides. Biomérieux customer service has requested the bottle subculture results for both impacted bottles. As there is no patient associated with this sample, there is no adverse event related to any patient's state of health. Biomérieux will open an internal investigation for this report.
 
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Brand NameINCUBATOR MOD LEFT W/RACKS 3D
Type of DeviceINCUBATOR MOD LEFT W/RACKS 3D
Manufacturer (Section D)
BIOMÉRIEUX, INC
595 anglum road
hazelwood MO 63042
Manufacturer (Section G)
BIOMÉRIEUX, INC
595 anglum road
hazelwood MO 63042
Manufacturer Contact
justine gouvier
5 rue des aqueducs
craponne, MO 69290
FR   69290
MDR Report Key13111082
MDR Text Key290472733
Report Number1950204-2021-00088
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026049577
UDI-Public03573026049577
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903505
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number210159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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