MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® CARBA SMART

Catalog Number 414685

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported there was no growth of a proteus mirabilis strain on chromid® carba smart agar (lot 1006566660).The customer reported that the patient had a positive cytobacterioligical urine exam, and was identified as a carrier of proteus mirabilis carba ndm-1.A rectal swab was tested on the chromid carba smart agar, and the customer stated they observed citrobacter growth, but the proteus carba ndm-1 did not grow.The strain had good growth on esbl (extended spectrum beta-lactamase) media.The customer tested the proteus strain from urine on the carba smart, and there was no growth.The customer stated that potentially an incorrect result was reported to a physician, and there was no patient impact or delay.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: a discrepancy or anomaly was not observed during a review of the device history record.Retain samples for the impacted lot was reviewed, although at the time the plates were inoculated the batch had already expired (august 2018).Additional retained samples from other lots were examined as part of the complaint investigation: fresh batch just after manufacturing 1006769620 (exp 27nov2018) which represents best conditions.Expired batch to check if the issue is appearing at expiration time: 1006570080 (exp 27aug18).Columbia agar used as a control to ensure that the recovery of all target strains was as intended.Strains tested are all the ones included in routine quality control (qc) in addition to a clinical strain.After 24 hours at 33-37 degrees c: e.Coli baa-2523 and e.Coli bba -2452 produced the expected colony appearance developing as spontaneous pink to burgundy coloration, producing beta-glucuronidase and beta-galactosidase klebsiella spp and serratia marcescens.1008091 produced the expected colony appearance developing as spontaneous bluish-green to bluish grey coloration producing beta-glucosidase (beta-glu).Proteus rettegeri 1103204 develops as spontaneous diffuse brown coloration of strains producing deaminase.Results were as expected on all three lots tested.Regarding the customer's strain, we confirmed the lack of growth in oxa and carba.Therefore further testing was as follows: confirmation of one (1) strain proteus mirabilis produced carbapenemase type ndm (pcr ndm positive).On the carb part of the biplate, the no growth of this strain (type oxa-48) is possible according to the product limitation (some enterobacterias strains with weak carbapenemase producing activity may not develop on the media).It is confirmed also lack of sensibility of chrom id carba smart medium, probably due to the atypical susceptibility to some drugs present in the medium.We have demonstrated that cmi for some drugs is lower than the drugs concentration of the media, therefore, the product perform within expected specifications.Strain and data will be forwarded to the r&d culture media team.Complaint trend analysis: a review of complaints registered for the impacted lot number: 1006566660 indicated that no other complaints were recorded.A review of complaints registered for the impacted reference: (b)(4) indicated that no performance issues are obtained due to quality of this product.Conclusion: the lot number record analysis as well as the retained samples analysis comply with biomérieux specifications.The investigation confirmed that lack of growth is due to susceptibility of this strain to the drugs included in the medium, therefore, medium is working according its specifications.

• Brand Name: CHROMID® CARBA SMART
• Type of Device: CHROMID® CARBA SMART
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 7850410
• MDR Text Key: 120264304
• Report Number: 3002769706-2018-00177
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K181092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2018
• Device Catalogue Number: 414685
• Device Lot Number: 1006566660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1