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

Catalog Number	20100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
An industry customer in (b)(6) notified biomerieux of obtaining an incorrect result in association with the with api® 20 e strips (ref.20100, lot 1007700960) while performing quality control testing with cect salmonella enterica strain.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.The customer performed oxidase testing on the salmonella enterica strain and confirmed the strain was oxidase negative.Salmonella enterica was cultured on tsi and urea agar; the expected results were obtained.The customer stated when testing the strain using multiple colonies to prepare the cell suspension, lot 1007700960 obtained the correct identifications.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.
Additional Manufacturer Narrative
This report was initially submitted following notification from an industry (non-clinical) customer in spain regarding incorrect results in association with api® 20 e strips (ref.20100, 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 was 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 on the preparation on the customer¿s internal saline solution 0.85%.Biomerieux recommends the customer to 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
• Common Device Name: API® 20 E
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10908419
• Report Number: 9615754-2020-00186
• Device Sequence Number: 3315499
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2021
• Device Catalogue Number: 20100
• Device Lot Number: 1007700960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1