MAUDE Adverse Event Report: BIOMERIEUX, SA API® 32 E 25 STRIPS

Catalog Number 32400

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

A customer in (b)(6) notified biomérieux of obtaining incorrect identifications when using api® id 32 e (ref 32400, lot 1007394100).The product reference 32400 is not registered in the united states; however, a similar product, api® id 20 e (ref 20100), is registered.The issue was observed with two quality control strains ((b)(4)), and two clinical samples (feces and sputum).The fecal specimen was initially identified as shewanella, then re-identified as pasteurella multocida.The customer got the expected identification of escherichia coli using the id 32 gn product.The sputum specimen initially obtained an unacceptable profile, and results interpreted visually gave the expected identification to serratia marcescens.The two quality control strains used by the customer were not the ones recommended in the ifu.But the customer also obtained incorrect identification for both strains.Escherichia coli (b)(4) was identified as salmonella cholerae arizona, and klebsiella pneumoniae (b)(4) was identified as enterobacter aerogenes.A field application specialist performed retest, but did not confirm the issue observed by the customer.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in china regarding incorrect identifications when using api® id 32 e (ref 32400, lot 1007394100).The product reference 32400 is not registered in the united states; however, a similar product, api® id 20 e (ref 20100), is registered.The issue was observed with two quality control strains (atcc® 25922¿ and atcc® 700603¿), and two clinical samples (feces and sputum).The fecal specimen was initially identified as shewanella, then re-identified as pasteurella multocida.The customer got the expected identification of escherichia coli using the id 32 gn product.The sputum specimen initially obtained an unacceptable profile, and results interpreted visually gave the expected identification to serratia marcescens.The two quality control strains used by the customer were not the ones recommended in the ifu.But the customer also obtained incorrect identification for both strains.Escherichia coli atcc® 25922¿ was identified as salmonella cholerae arizona, and klebsiella pneumoniae atcc® 700603¿ was identified as enterobacter aerogenes.A field application specialist performed a retest on the patient strains, but did not confirm the issue observed by the customer.A biomérieux internal investigation was performed on the atcc® quality control strains to check the performance of the impacted lot number.Retained samples analysis: biomérieux tested retains from the customer lot 1007394100 and an internal reference lot 1007467090.The conformity was confirmed with the atcc® quality control strains tested for the release of this reference: escherichia coli atcc® 11775¿.Salmonella spp atcc® 35664¿.Raoultella ornithinolitica atcc® 31898¿.Stenotrophomonas maltophilia atcc® 51331¿.The results obtained for these strains with both lots are in agreement with quality control specifications.The customer issue was not reproduced on package insert quality control strain and the retained sample tested.It was recommended for the customer to repeat the instruction for use step by step to validate methodology and perform quality control tests with strains recommended in the package insert.

• Brand Name: API® 32 E 25 STRIPS
• Type of Device: API® 32 E 25 STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 9527737
• MDR Text Key: 217723779
• Report Number: 9615754-2019-00146
• Device Sequence Number: 1
• Product Code: JSS
• 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,u
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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 Expiration Date: 06/04/2020
• Device Catalogue Number: 32400
• Device Lot Number: 1007394100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1