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

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
A customer in (b)(6) notified biomérieux of false positive citrate results for escherichia coli (e.Coli) atcc® 25922 in association with api® 20 e 25 strips (ref.20100, lot 1006601250).The customer performed testing four (4) times using api® 20 e 25strips lot 1006601250 with two (2) strains of e.Coli atcc® 25922 and obtained a positive result for all assays.E.Coli atcc® 25922 was also tested in parallel using api® 20 e 25strips lot 1006611730, and obtained a negative citrate result.The customer confirmed the expected citrate result for e.Coli atcc® 25922 is negative.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated for a customer report of obtaining false positive citrate results for escherichia coli (e.Coli) atcc® 25922 in association with api® 20 e 25 strips (ref.20100, lot 1006601250).The customer performed testing four (4) times using api® 20 e 25strips lot 1006601250 with two (2) strains of e.Coli atcc® 25922 and obtained a positive result for all assays.The customer confirmed the expected citrate result for e.Coli atcc® 25922 is negative.The customer returned the remaining strips of the impacted lot number for further investigation.The investigation also included an analysis of retained samples and trend analysis.1.Retained samples analysis: the conformity of impacted lot number 1006601250, and an internal reference lot number 1007254260 used for the investigation, was confirmed with the atcc quality control strains tested for the release of this reference: atcc 13047 enterobacter cloacae.Atcc 35659 proteus mirabilis.Atcc 25922 escherichia coli.Atcc 35657 klebsiella pneumoniae ssp pneumoniae.Atcc 51331 stenotrophomonas maltophilia.The results obtained with these strains and both lots are in agreement with our quality control specifications.2.Returned samples analysis: the customer's returned remaining strips of the lot number 1006601250 were investigated.The results with the quality control strain escherichia coli atcc 25922 conformed to the specification.The result of the citrate test (cit) was negative as expected.The customer's reported issue was not reproduced.3.Complaints trend analysis: no other complaint was registered on lot number 1006601250.One investigation was opened in the past on another lot number of this reference product for a reactivity problem with the test cit (citrate) and escherichia coli atcc 25922.The problem has not been reproduced either.4.Conclusion: the results obtained with the atcc quality control strains tested during the investigation were within product specifications.The customer's reported issue was not reproduced on the retained samples nor the returned strips of the lot 1006601250.The trend analysis of the complaints did not show any problem for this reference.

• Brand Name: API® 20 E 25 STRIPS
• Common Device Name: API® 20 E 25 STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9293357
• Report Number: 9615754-2019-00116
• Device Sequence Number: 2172078
• Product Code: JTO
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2019
• Device Catalogue Number: 20100
• Device Lot Number: 1006601250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1