MAUDE Adverse Event Report: BIOMERIEUX SA API® 20 STREP

Model Number	20600
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in france notified biomérieux of discrepant results associated with api® 20 strep.The customer reported that the api® 20 strep test gave a false identification.The false identification of aerococcus viridans was reported to the clinician.There was no injury to patient due to the false identification, however there was a delay greater than 24 hours because the first identification was performed on vitek® ms and then subsequent testing on the api® 20 strep strip.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) notified biomérieux of a false identification of aerococcus viridans associated with api® 20 strep.The customer submitted the strain(s) for evaluation.An investigation was performed.Two strains (°643 aerococcus viridans and strain n°519 veillonella parvula) were previously submitted by the customer as part of another investigation.Testing could no be performed on this strain n°519, as no growth was seen in the tube sent by the customer.Strain n°519 veillonella parvula was received again from the customer in anaerobic condition on cos media.No growth was seen on the plate at reception.The strain was incubated at 37°c after changing the anaerobic bag, but no growth was seen after 24 hours and 72 hours of incubation.The strain n°643, results were : vitek® ms v3 kb v3.0 = 5 x noid (same result as customer).Api® 20 strep = 2 x aerococcus viridans 99% (same result as customer).16s full sequencing gave an excellent identification to the species a.Sanguinicola (99.91%).The species aerococcus sanguinicola is not included in the api® 20 strep knowledge base (kb).There is a limitation not claimed in the kb : testing of unclaimed species may result in an unidentified result or a misidentification.In conclusion, api® 20 strep performed as expected.

• Brand Name: API® 20 STREP
• Common Device Name: API® 20 STREP
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 6572875
• Report Number: 3002769706-2017-00124
• Device Sequence Number: 19027968
• Product Code: JSS
• UDI-Device Identifier: 03573026048440
• UDI-Public: 03573026048440
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K813610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 12/13/2016
• Device Model Number: 20600
• Device Lot Number: 1004525130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1