MAUDE Adverse Event Report: BIOMÉRIEUX, SA API 20 NE 25STRIPS+25MEDIA

Model Number 20050

Device Problem 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 ne is a qualitative standardized system for the identification of non-fastidious, non-enteric gram-negative rods (for example, pseudomonas, acinetobacter, moraxella, vibrio, aeromonas).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.Incident description: a customer in singapore reported to biomérieux a qc failure in association with the product api 20 ne (ref.(b)(4), batch 1008507370, expiry date (b)(6) 2022) with a qc strain.The customer has tested aeromonas hydrophilia atcc® 35654¿ with api 20 ne.It was reported the user attempted qc three times; however, all three tests failed on no3, trp, glu, adh, ure, esc, and gel.The customer tested the qc strain using vitek 2 gn id card, and it proved as a.Hydrophilia with intended positive biochemical reactions.Manual nitrate test has been performed with the qc strain, and confirmed positivity.As there is no patient associated with this qc strain, there is no adverse event related to any patient's state of health.An investigation has been initiated.

Event Description

Intended use: api® 20 ne is a qualitative standardized system for the identification of non-fastidious, non-enteric gram-negative rods (for example, pseudomonas, acinetobacter, moraxella, vibrio, aeromonas).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.Incident description: a customer in singapore reported to biomérieux a qc failure in association with the product api 20 ne (ref.20050, batch 1008507370, expiry date 14-jan-2022) with a qc strain.The customer has tested aeromonas hydrophilia atcc® 35654¿ with api 20 ne.It was reported the user attempted qc three times; however, all three tests failed on no3, trp, glu, adh, ure, esc, and gel.The customer tested the qc strain using vitek 2 gn id card, and it proved as a.Hydrophilia with intended positive biochemical reactions.Manual nitrate test has been performed with the qc strain, and confirmed positivity.As there is no patient associated with this qc strain, there is no adverse event related to any patient's state of health.An investigation has been initiated.

Manufacturer Narrative

A customer in singapore reported to biomérieux a qc failure in association with the product api® 20 ne (ref.20050, batch 1008507370, expiry date 14-jan-2022) with a qc strain.Investigation retain sample testing: the retained samples for the impacted lot number 1008507370 were tested in parallel with an internal lot number used as a reference lot (reference 20050, lot 1008520080, expiry date 14-jan-2022).The investigation was performed using the atcc® qc strains mentioned in the api 20 ne package insert (aeromonas hydrophila atcc® 35654¿, alcaligenes faecalis ssp faecalis atcc® 35655¿, sphingobacterium multivorum atcc® 35656¿ and pseudomonas aeruginosa atcc® 27853¿).These strains were tested according to the protocol used to release each lot number.Results obtained for the four strains were consistent with the expected results and each other.History review: the investigator reviewed the complaints database to search for other, similar reports.No other complaints are documented against the customer¿s lot number, nor does there appear to be a negative trend for product api 20 ne (ref.20050).Conclusion the quality control strains tested on the retained samples complied with specifications for the impacted lot number 1008507370.The results on the four qc strains, including the aeromonas hydrophila atcc 35654 (organism reported by the customer) were within specifications.In addition, equivalent results were obtained on the impacted lot number 1008507370 and the lot number used as a reference.The biomérieux investigator was unable to reproduce or confirm the malfunction observed by the customer.The most common reasons for quality control sample failures are 1) using ape suspension medium instead of api nacl (b)(4) medium, 2) turbidity of the inoculum (in the correct medium) less than 0.5 mcfarland, 3) sample suspension is not used immediately following preparation, or 4) a problem with the qc strain.

• Brand Name: API 20 NE 25STRIPS+25MEDIA
• Type of Device: API 20 NE 25STRIPS+25MEDIA
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3, route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3, route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12760583
• MDR Text Key: 286075547
• Report Number: 9615754-2021-00280
• Device Sequence Number: 1
• Product Code: JSS
• UDI-Device Identifier: 03573026047702
• UDI-Public: 03573026047702
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 20050
• Device Catalogue Number: 20050
• Device Lot Number: 1008507370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1