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

Catalog Number 20100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

An industry customer in (b)(6) notified biomerieux of obtaining incorrect results in association with the with api® 20 e strips (ref.20100, lot 1007700960) while performing quality control testing with cect escherichia coli.The customer stated when testing a single isolated colony using lot 1007700960 no growth was observed in the strip and a result of 0000000 (negative) was obtained.The customer re-incubated the strip for another twenty-four (24) hours at 36ºc; the same result of 0000000(negative) was obtained.This incorrect result was obtained for cect escherichia coli.The escherichia coli strain was gram stained and obtained the expected result of gram-negative bacilli.The customer stated when testing the strain using multiple colonies to prepare the cell suspension, lot 1007700960 obtained the correct identification.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomerieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from an industry (non-clinical) customer in spain regarding incorrect results in association with the with api® 20 e strips ((b)(4), lot 1007700960) while performing quality control testing with cect escherichia coli and salmonella enterica strains.A batch record analysis of the customer¿s lot (1007700960) was performed.No non-conformity or observation were found during the manufacturing process and quality control process related to the customer¿s issue.The following quality control strains included in the package insert 07584 l were tested on the retain of the customer¿s lot (1007700960) and a reference lot api® 20 e strips (1007865190): 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.The results were compliant to specifications for both lots.The customer¿s issue was not reproduced during the investigation.A potential root cause could be a problem with the preparation on the customer¿s internal saline solution 0.85%.Biomérieux recommends the customer use api nacl 0.85% medium (5ml) reference (b)(4), or api suspension medium (5ml) reference (b)(4) as described in the package insert 07584 to inoculate the api® 20 e strips.

• Brand Name: API 20 E
• Type of Device: API® 20 E
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10908390
• MDR Text Key: 230489450
• Report Number: 9615754-2020-00185
• Device Sequence Number: 1
• Product Code: JSS
• 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,u
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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 Expiration Date: 03/10/2021
• Device Catalogue Number: 20100
• Device Lot Number: 1007700960
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1