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

Catalog Number 20100

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: api® 20 e is a qualitative standardized system for the identification of enterobacteriaceae and other non-fastidious gram-negative rods.It uses miniaturized tests as well as a specially adapted database.Issue description: a customer in spain has notified biomérieux that he obtained a misidentification of yersinia intermedia as raoultella using the gallery api 20 e (ref.20100, lot number: 1008824240, expiration date: 07/12/2022).The customer has identified raoultella ornithinolytica (98.9% id) rather than yersinia intermedia (cect 4317 / wdcm 00217).Biomérieux customer service did not identify any off-label use by the customer while preparing the strip.At the time of the assessment, 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.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context: a customer in spain has notified biomérieux that he obtained a misidentification of yersinia intermedia as raoultella using the gallery api 20 e (ref.20100, lot number 1008824240, expiration date: 07/12/2022).The customer has identified raoultella ornithinolytica (98,9% id) rather than yersinia intermedia (cect 4317 / wdcm 00217).Complaint trend analysis and device history record : there is no capa related to the customer¿s complaint recorded.No non-conformity during manufacturing and quality control processes were observed for the lot 1008824240.A complaint history review was completed for this issue during the last 13 month time frame with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.Investigation: 1 / performance of the lot: the performance of the api® 20e lot 1008824240 was controlled with strains included in the package insert in comparison with a referent lot following the quality control procedure.Strains tested: proteus mirabilis atcc® 35659¿ cq 106, enterobacter cloacae atcc® 13047¿ cq 124, escherichia coli atcc® 25922¿ cq 126, klebsiella pneumoniae ssp pneumoniae atcc® 35657¿ / 13882¿ cq 112, stenotrophomonas maltophilia atcc® 51331¿ cq 219.Lots tested: api 20 e : reference 20100, lot 1008824240 (exp : 07 dec 2022) : lot related to the complaint.Reference 20160, lot 1009336420 (exp : 19 sep 2023) : reference lot.Results: for the five (5) stains tested, results are compliant with the theoretical profile for both lots and no difference of results were observed for a same strain between the two lots tested.The lot 1008824240, related to the complaint, is not called into question.2/ performance of an equivalent strain: the strain was provided by the customer.The profile of the customer strain was controlled with the api 20e lot 1008824240 in comparison with a referent lot, following the package insert procedure.Lots tested: api 20 e : reference 20100, lot 1008824240 (exp : 07 dec 2022) : lot related to the complaint.Reference 20160, lot 1009336420 (exp : 19 sep 2023) : reference lot.Results: for both strips tested, the results of customer strain were superposable between the lot related to the complaint and the referent lot.The customer issue is not reproduced for the tests cit and vp which were clearly negative.However, the customer issue is partially reproduced for the test mel which was +/-.The api identification code obtained for the two strips tested is equivalent (#1154773) corresponding to an acceptable identification as yersinia frederiksennii/ intermedia on web api.Conclusion: the batch record review of api 20 e, reference 20100, batch 1008824240 did not highlight any anomaly during manufacturing or quality control which could lead to an identification issue.There is neither trend of complaints on the batch 1008824240, nor on product reference 20100 regarding the issue reported.Analysis were made on retained samples from batch 1088824240 on qc strains, internal strains of yersinia intermedia atcc 29909 and on the strain the customer returned yersinia intermedia cect 4317; by comparison of batch 1008824240 to a referent batch number 1009336420.According to the investigation, the results are : for the five qc strains tested, the results are compliant to the specifications.For yersinia intermedia atcc 29909, the identification is a good identification as yersinia frederiksennii/ intermedia, with negative results for vp, cit et mel, as expected for this strain in our database.For yersinia intermedia cect 4317, both vp and cit tests were negative, but mel test was doubtful +/-, leading to an acceptable identification as yersinia frederiksennii/ intermedia.In conclusion, the performance of the batch 1008824240 of api 20e is not questioned.The expected identification was obtained as yersinia frederiksennii/ intermedia.The issue seems to be linked to the specificity of the customer strain.

Event Description

Intended use: api® 20 e is a qualitative standardized system for the identification of enterobacteriaceae and other non-fastidious gram-negative rods.It uses miniaturized tests as well as a specially adapted database.Issue description: a customer in spain has notified biomérieux that he obtained a misidentification of yersinia intermedia as raoultella using the gallery api 20 e (ref.20100, lot number 1008824240, expiration date: 07/12/2022).The customer has identified raoultella ornithinolytica (98.9% id) rather than yersinia intermedia (cect 4317 / wdcm 00217).Biomérieux customer service did not identify any off-label use by the customer while preparing the strip.At the time of the assessment, 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.A biomérieux internal investigation will be initiated.

• Brand Name: API 20 E 25STRIPS
• Type of Device: API 20 E 25STRIPS
• 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: justine gouvier ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15274921
• MDR Text Key: 305261047
• Report Number: 9615754-2022-00101
• Device Sequence Number: 1
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2022
• Device Catalogue Number: 20100
• Device Lot Number: 1008824240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1