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

Model Number	20600
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: api® 20 strep is a qualitative standardized system for the group or species identification of most streptococci and enterococci, and those most common related organisms.It uses miniaturized tests as well as specially adapted database.Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.Description of the issue: a customer in united states notified of obtaining false positive for esculin ferric citrate (esc) when testing a quality control strain ; streptococcus equi spp zooepidemicus atcc® 700400¿ with the api 20 strep - reference 20600 - expiration date 21/09/2021.The reaction in the strip does not match with a good pathogen profile.The test has been performed three times and false positive for esc has been obtained each time.As it concerns a quality control test, no patient impact has been reported as a consequence of this false result.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false positive result for esculin ferric citrate (esc) when testing quality control strain streptococcus equi spp zooepidemicus atcc® 700400¿ with the api® 20 strep- reference (b)(4)- expiration date 21/09/2021.The reaction in the strip does not match with the good pathogen profile.Retained samples analysis: the retained sample for the impacted lot number 1008285100 reported by the customer was tested in parallel with an internal lot number used as reference.The tests were performed using the qc strains streptococcus equi ssp zooepidemicus atcc 700400 and streptococcus uberis atcc® 700407¿ mentioned in the package insert 07625 version m.The qc results obtained for the tested strains are in accordance with the expected specifications for the two api 20 strep lots tested, particularly for the strain streptococcus equi ssp zooepidemicus atcc 700400 reported by the customer.Batch record analysis: no non-conformity during manufacturing and quality control processes were observed for the lot 1008285100 which could explain the issue observed by the customer.Complaint analysis: a complaint trending analysis was performed on the lot number 1008285100.No other complaints were registered for this lot number.Furthermore, since 2018, the complaint analysis does not show performance issue on the product api® 20 strep, reference (b)(4).Conclusion: the results of quality control obtained during our investigation on the impacted api® 20 strep, reference (b)(4) lot 1008285100 complied with specifications.The batch record analysis does not show non-conformity during manufacturing and quality control processes.The trend analysis of the complaints does not show any deviation on the product reference api® 20 strep, reference (b)(4).As the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.

• Brand Name: API 20 STREP 25STRIPS+25MEDIA
• Common Device Name: API 20 STREP 25STRIPS+25MEDIA
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11895173
• Report Number: 9615754-2021-00170
• Device Sequence Number: 3400019
• Product Code: JTO
• UDI-Device Identifier: 03573026048440
• UDI-Public: 03573026048440
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: CL 1 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): 06/29/2021

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: 09/21/2021
• Device Model Number: 20600
• Device Catalogue Number: 20600
• Device Lot Number: 1008285100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1