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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API 20 E 25 STRIPS API® 20 E 25 STRIPS

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BIOMERIEUX, SA API 20 E 25 STRIPS API® 20 E 25 STRIPS Back to Search Results
Catalog Number 20100
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
An internal complaint was initiated following a review of a 2019 scientific publication entitled, "challenges in identification of enteroinvasive escherichia coli and shigella spp. In lebanon" by halimeh f. , et al. The purpose of the study was to evaluate tools available in lebanon to differentiate between escherichia coli and shigella spp. Diarrheal diseases are a major public health issue worldwide and escherichia coli and shigella spp. Are two of the most common causes. Escherichia coli and shigella spp. Are very similar genetically which makes it hard to differentiate between them. The api ® 20 e (reference # 20100) was one of the tools used in the study along with maldi-tof, serological testing, duplex pcr targeting ipah (present in shigella spp. And enteroinvasive e. Coli "eiec") and lacy (found in e. Coli including eiec but not shigella spp. ) as well as gyrb gene sequencing. Antibiotic susceptibility was investigated as well as shiga-toxin production. The api ® 20 e identified 43 isolates from stool samples collected from july 2010 to september 2016 as shigella spp. But gyrb gene sequencing method identified them as e. Coli. The lab used serological and molecular analysis (pcr) to further define the isolates. The results of duplex pcr targeting lacy and ipah genes were either e. Coli (5) eiec (26), inactive e. Coli (1), or shigella spp (11). These results suggest that the api ® 20 e misidentified some of the isolates. The api ® 20 e package insert does state if shigella is identified then serological identification must be performed to confirm the bacterial identification. Agglutination tests were used to further identify the isolates with the following results: 17 isolates reacted with shigella sonnei, shigella boydii, s. Flexneri, and shigella dysenteriae antisera, 2 isolates agglutinated with all species antisera, 1 isolate cross-reacted with s. Boydii, s. Sonnei, and s. Dysenteriae antisera, 23 isolates didn't react with any antisera. In summary, 23 out of the 43 isolates could not be classified as shigella spp. Which further suggests that the api ® 20 e misidentified some of the isolates. There is no indication in the publication that the discrepant results led to any adverse event related to the patients' state of health. Biomérieux investigation will be initiated.
 
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Brand NameAPI 20 E 25 STRIPS
Type of DeviceAPI® 20 E 25 STRIPS
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme, 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme, 38390
FR 38390
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
MDR Report Key10162703
MDR Text Key226993314
Report Number9615754-2020-00091
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeLE
PMA/PMN Number
C1 EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number20100
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 Received05/21/2021
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 Initial

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