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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA

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BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA Back to Search Results
Model Number 10300
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Intended use: api® listeria is a qualitative standardized system for the identification of listeria. It uses miniaturized tests as well as a specially adapted database. Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software. The complete list of those organisms that it is possible to identify with this system is given in the technical brochure - information for identification software. Incident description: a customer in (b)(6) reported to biomérieux discordant results (potential misidentification) in association with the product api listeria 10strips+10media (ref 10300, batch 1008392040, expiry date 15-oct-2021) with an external quality assessment (eqa) sample. The customer has tested an atcc strain (atcc reference not reported) with mini-vidas, with api listeria as confirmation method and another method for identification (method and results not reported): he reported that he obtained discrepant results. It is suspected that there was an user error regarding the zym b (reagent used for test reading and interpretation): it was reported that they used zym b, 46 and 64 days after opening for some strips, whereas it is important not to use zym b after 15 days, or it would affect the results. Moreover in this context there are potential false results due to potential erroneous interpretation for which the customer requested assistance to biomerieux customer service. At the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to the patient's state of health. An investigation will be initiated.
 
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Brand NameAPI LISTERIA 10STRIPS+10MEDIA
Type of DeviceAPI LISTERIA 10STRIPS+10MEDIA
Manufacturer (Section D)
BIOMERIEUX, SA
3, route de port michaud
la balme les grottes 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3, route de port michaud
la balme les grottes
Manufacturer Contact
jeff scanlan
595 anglum road
hazelwood, MO 63042
MDR Report Key12457290
MDR Text Key280689401
Report Number9615754-2021-00238
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
C1 EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/15/2021
Device Model Number10300
Device Catalogue Number10300
Device Lot Number1008392040
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2020
Type of Device Usage

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