MAUDE Adverse Event Report: BIOMERIEUX SA RAPIDEC® CARBA NP (10) US

Model Number	RAPIDEC® CARBA NP
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: rapidec® carba np is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative detection of carbapenemase enzymes in enterobacteriaceae and pseudomonas aeruginosa colonies that have elevated mic values to any carbapenem.Rapidec® carba np is performed on pure colonies grown on non-selective sheep blood agar culture media.Rapidec® carba np is intended as an aid in the prevention and control of infection caused by carbapenemase-producing enterobacteriaceae and pseudomonas aeruginosa.Rapidec® carba np is not intended to guide or monitor the treatment for these bacterial infections.A negative result does not preclude the presence of carbapenemase enzymes.The ability of the rapidec® carba np to detect carbapenemases enzymes encoded by genetic marker other than kpc, ndm, oxa-48, vim and imp has not been established.Rapidec® carba np testing should be used in conjunction with other laboratory tests including antimicrobial susceptibility testing.Description: a customer in the united states notified biomérieux of obtaining false positive results for a proteus mirabilis strain in association with the rapidec® carba np (10) us (ref 417824, lot 1008199570).The customer stated that the isolate was identified as proteus mirabilis by microscan.The proteus mirabilis isolate was analyzed with the rapidec® carba np and the customer reported that they obtained a "weak positive result" with initial testing.The customer sent the strain out for complete genome testing and the results came back as negative.Repeat analysis with the rapidec® carba np also obtained a weak positive result.The rapidec® carba np test is based on the detection of imipenem hydrolysis by carbapenemase-producing bacteria.Global customer service (gcs) reviewed the information provided by the customer and confirmed that the package insert for the rapidec® carba np includes a documented limitation for proteus species which states that proteus species, providencia species, and morganella species may have elevated imipenem mics due to intrinsic resistance mechanisms.Gcs stated that this could explain the weak positive result observed by the customer.There is no indication or report from the customer that the false positive results led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be conducted.
Additional Manufacturer Narrative
A customer in the united states notified biomérieux that they obtained discrepant results between rapidec® carba np (ref.(b)(4) lot# 1008199570) and microscan method for a patient strain of proteus mirabilis.The customer's results were weakly positive with rapidec® carba np and negative using microscan.Investigation: the investigator reviewed the batch record for lot# 1008199570 and confirmed there were no non-conformities during the manufacturing and quality control processes.Complaint trending analysis was performed on the lot number 1008199570.No other complaints were registered for this lot number.Review of the complaint database does not show any performance issue on the product.Retained sample testing: lot# 1008199570 used the same semi-finished products as those used for the rapidec® carba np lot# 1008199550.Retained sample for the lot# 1008199550 was tested recently; the results of these tests were used for the current investigation.Lot#1008199550 was tested in parallel with one internal lot number (1008586780) used as reference.Tests were performed using the quality control (qc) strains klebsiella pneumoniae atcc® baa 1705¿, klebsiella pneumoniae atcc® baa 1706¿ and klebsiella pneumoniae atcc® 700603¿ included in the package insert.All the results obtained were in accordance with the specifications.No difference in results was observed between the lot 1008199550 related to the complaint and the reference lot.Conclusion: biomérieux was unable to reproduce or confirm the customer's issue.The investigator did not identify evidence of any non-conformity during manufacturing and quality control processes, nor did they find other reports of problems with the lot in question.Customer confirmed that the proteus mirabilis patient strain is not available to submit; further investigation is not possible.

• Brand Name: RAPIDEC® CARBA NP (10) US
• Common Device Name: RAPIDEC® CARBA NP (10) US
• 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: 12619526
• Report Number: 9615754-2021-00266
• Device Sequence Number: 11116489
• Product Code: PTJ
• UDI-Device Identifier: 03573026464370
• UDI-Public: 03573026464370
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 04/06/2022
• Device Model Number: RAPIDEC® CARBA NP
• Device Catalogue Number: 417824
• Device Lot Number: 1008199570
• 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: 09/13/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/24/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown