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

Catalog Number 20100

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

Manufacturer Narrative

An investigation was initiated in response to the 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.Complaint trend analysis: a review of complaints from 2018 to may2021 did not identify this type of misidentification as a trend for the api 20 e (ref 20100 or ref 20160).Additionally, a review of scientific publications from 2015 to 2021 did not identify any other publications related to api 20 e misidentifications of e.Coli as shigella spp.Publication data investigation: the article describes a study which objective was to evaluate the routine identification tools available in lebanon (tripoli) for the differentiation of e.Coli and shigella spp.43 clinical isolates were then tested using api 20e strip, maldi-tof (bruker), agglutination tests using antiserum antibodies (bio-rad) and molecular identification (pcr and whole genome sequencing).The 43 strains were identified as shigella spp.Using api 20e.After performing the serological testing and the pcr, those isolates were defined as a diverse group belonging to shigella spp., and e.Coli.Nevertheless the sequencing of gyrb gene, which was recently described as a suitable marker for distinguishing e.Coli and shigella spp., identified all isolates as e.Coli and the maldi-tof results were aligned with the sequencing (43 strains identified as e.Coli).E.Coli and shigella spp.Are very similar, genetically.Differentiation of e.Coli and shigella spp.Is a known limitation of biochemical identification and this limitation is documented for api 20 e in the "limitations of the method" section of the technical brochure information for identification software: "if salmonella or shigella are identified, serological identification must be performed to confirm the bacterial identification".Additionally, apiweb warns the customer with a note when a shigella spp.Strain is identified: "confirm by serological tests / highly pathogenic organism".By following the api 20 e instructions for use (ifu) and apiweb note, all isolates identified as shigella spp.Should be tested with serological testing which is considered as a reference method to confirm the identification.Conclusion: the risk of misidentification between e.Coli and shigella spp.Using api 20 e strip is mitigated by the limitation in the ifu and in apiweb notes.No trends were identified related to api 20 e for misidentifications of e.Coli as shigella spp.There is no evidence that the api 20e is outside its expected level of performance.

• Brand Name: API 20 E 25 STRIPS
• Type of Device: API® 20 E 25 STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 10162703
• MDR Text Key: 226993314
• Report Number: 9615754-2020-00091
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1