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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA - 10300

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BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA - 10300 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 organisms that it is possible to identify with this system is given in the associated technical brochure - information for identification software. Incident description: on the (b)(6) 2021, a customer in (b)(6) reported to biomérieux a potential misidentification with the product api listeria (ref 10300, batch 1008506770, expiry date 21-dec-2021) with an external quality assessment (eqa) sample. The customer tested an eqa sample, 20a round ma191, from lgc and has reported an issue with the confirmation part of the test. A confirmation using api listeria was performed and for all analysts, the result was very good identification of listeria grayi 99. 8%. Based on the report from lgc: this sample contained a ¿-haemolytic strain of listeria innocua; 46. 7% of participants incorrectly reported the presence of listeria monocytogenes. This strain was obtained for use in the mars wrigley pt scheme and has undergone whole genome sequencing and identified as listeria innocua, the data provided being compliant with mars wrigley requirements. Results for the detection of listeria species were 96. 3% correct, indicating no issue with the quality of the sample batch and that an incorrect result is likely to be due to identification or confirmatory issues. There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health. An investigation will be initiated.
 
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Brand NameAPI LISTERIA 10STRIPS+10MEDIA - 10300
Type of DeviceAPI LISTERIA 10STRIPS+10MEDIA
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
MDR Report Key11995421
MDR Text Key281523831
Report Number9615754-2021-00175
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
PMA/PMN Number
C1 EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/21/2021
Device Model Number10300
Device Catalogue Number10300
Device Lot Number1008506770
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No

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