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) notified biomerieux of no growth and delayed results associated with chromid® carba smart (reference (b)(4)).The customer reported observing no growth on chromid for escherichia coli on the oxa 48 side and small growth on the carba side of the plate.The antibiogram of the strain was resistant and the customer sent it to a reference laboratory.At the reference laboratory e.Coli was confirmed with the presence of a carbapenamse oxa 48 and the presence of an extended-spectrum beta-lactamases (esbl).Patient treatment was not impacted by this discrepancy.Initial treatment of the patient occurred in (b)(6) with bactrim (r), which did not relieve the patient's complaints for one (1) week.The patient sought further treatment in (b)(6).The patient's condition required nitrofurantoin according to the antibiogram, which he received in (b)(6), but hospitalization was not required.The following results were reported to the physician: "sent to the reference lab due to suspected cpe." after one (1) week the confirmation by the reference lab was reported to the doctor: "cpe" (carbapenem-producing enterobacteriaceae), carbapenemase type oxa-48.Results were delayed due to the discrepant results by two (2) to three (3) days.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 for the lot in question.Retrained samples were reviewed from the impacted lot.At the time the complaint was received on 19sep2018, the suspected lot had already expired (18aug2018).In addition to the retained sample lot another lot that had not yet expired was part of the complaint investigation (lot 1006787500 expiry date of 02dec2018).Strains tested included routine qc control and a clinical strain after 24 hours between 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 which produced the expected colony appearance developing as spontaneous bluish-green to bluish-grey coloration producing beta glucosidase.Proteus rettegeri 1103204 develops as spontaneous diffuse brown coloration of strains producing deaminase.Testing of these lots produced expected results.Further testing confirmed that one strain of escherichia coli producer carbapenemase type oxa-48 (pcr oxa-48 like positive).On the carb part of the biplate, the no growth of this strain (type oxa-48) is possible according to the product limitation as defined in the package insert.On the oxa part of the biplate, the customer issue was duplicated in-house (i.E.No growth).A lack of chrom id carba smart medium, likely due to the atypical susceptibility to some drugs present in the medium is the root cause of the issue.Internally, biomerieux has demonstrated that cmi for some drugs is lower than the drug concentration in the media, therefore, the product performed as expected.The device history records as well as the retained samples review are within manufacturing specification.The issue observed by the customer was reproduced on the retained sample plates tested at various dates of manufacture on non-routine strains.Upon further investigation, this particular strain confirmed that the lack of growth is due to susceptibility of this strain to the drugs included in the medium; therefore, the medium is working according its specifications.In addition, no other complaints were registered on this lot number.Complaints will continue to be monitored on this reference.

• 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: 7918708
• MDR Text Key: 124861446
• Report Number: 3002769706-2018-00189
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2018
• Device Catalogue Number: 414685
• Device Lot Number: 1006583300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1