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

Catalog Number	20701
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) contacted biomérieux regarding an interpretation question in association with the api rapid 20 e¿ test strips (ref.20701, lot 1008047921).The customer questioned the color interpretation of the cit well in the rapid 20 e¿ test strip when testing a quality control s.Entereditis atcc® 13076¿ and proteus hauseri atcc® 13315¿ isolates, with expected result of cit positive (green to blue) and cit negative (yellow), respectively.The rapid 20 e¿ test strip package insert version g states "yellow" results are interpreted as negative while a "green to blue" result is positive.The customer obtained the expected positive result for s.Entereditis atcc® 13076¿; however, the cit well for proteus hauseri atcc® 13315¿ was green-yellow in color.The customer asked if this was an incorrect result as the previous version of the package insert (version f) stated a cit well of "yellow to yellow-green'" was considered a negative result.Biomérieux customer service and labeling departments confirmed an error in the package insert reading table (version g).They confirmed the negative result color for cit test should be "yellow to yellow-green", as in the previous package insert (version f), instead of just yellow.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 has initiated an internal investigation.
Additional Manufacturer Narrative
A customer in san marino notified biomerieux of an interpretation question in association with the api rapid 20 e¿ test strips (ref.20701, lot 1008047921).Investigation.A review of the package insert, version g, identified one error in the reading and interpretation section, reading table, page 6.The negative cit test result is incorrectly stated as ¿yellow¿ instead of ¿yellow to yellow- green¿.The cause of this error was identified as a human error when the package insert 11674 was updated from version f to version g.It could lead to difficulties in interpretation and in the worst case false positive results for the cit test, thus possibly no identification (delayed results) or identification errors.It is important to note that lot# 1008047921, the customer¿s lot, is associated with package insert version f (not package insert version g).The search that is performed in resource center must be performed by lot number in order to obtain the correct package insert.Package insert 11674 version g is only associated with two lot numbers (1008332150 and 1008787180).Following this error the following actions have been implemented : - a change was implemented to correct this error on package insert 11674 version g and the new version of package insert (11674 version g1) is available on resource center since the 22nd of october 2021.- a field safety corrective action (fsca 5387) was implemented for lot numbers 1008332150 and 1008787180 due to the risk of potential false positive results for the cit test, thus possibly no identification (delayed results) or identification errors.- a corrective and preventive action (capa) file was opened to further investigate the root cause and define the necessary actions to avoid similar issues.Conclusion.A review of package insert, reference 20701 (rapid 20 e tm), version g, identified a human error in the reading table.The negative cit test result is incorrectly stated as ¿yellow¿ instead of ¿yellow to yellow- green¿.Following this error the following actions have been implemented : - the corrected version of package insert (11674 version g1) is available on resource center (posted 22nd of october 2021).- a field safety corrective action (fsca 5387) was implemented.- a corrective and preventive action (capa) file was opened to further investigate the root cause and define the necessary actions to avoid similar issues.

• Brand Name: API RAPID 20 E 25STRIPS
• Common Device Name: API RAPID 20 E 25 STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12705936
• Report Number: 9615754-2021-00275
• Device Sequence Number: 16510959
• Product Code: JSS
• UDI-Device Identifier: 03573026048617
• UDI-Public: 03573026048617
• Combination Product (Y/N): N
• Initial Reporter Country: SM
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 10/26/2021
• Device Catalogue Number: 20701
• Device Lot Number: 1008047921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FSCA 5387
• Patient Sequence Number: 1
• Patient Sex: Unknown