MAUDE Adverse Event Report: BIOMÉRIEUX S.A. CHROMID CARBA SMART; CHROMID¿ CARBA SMART

Catalog Number 414685

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a discrepancy with chromid¿ carba smart(reference (b)(4) regarding several strains that did not grow on chromid¿ carba smart.Several lots were impacted and the customer reported that those strains grew on chromid¿ esbl.The customer sent all the strains to cnr who confirmed by pcr oxa 48.The customer reported that there was no impact or adverse event to the patient because all the strains grew on chromid¿ esbl, and no incorrect results were provided to the physician.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a discrepancy with chromid carba smart(reference 414685) regarding several strains that did not grow on chromid carba smart.An investigation was performed.A review of quality records confirmed the lot conformed to the manufacturing and release specifications.Retention samples from the customer lot and two random lots of chromid carba smart were tested using internal quality control strains.Columbia agar was used as a control to make sure that the recovery of all target strains was intended.The cpe internal quality control strains used for testing the chromid carba smart were: escherichia coli2 ( ref atcc baa-2523) klebsiella pneumoniae2 ( ref 1104053) nctc 13442 klebsiella pneumoniae2 ( ref 1103199) klebsiella pneumoniae2 ( ref 1103203) klebsiella pneumoniae2 ( ref 0804167) after 18-24 hours at 33-37ºc the performance was as expected, without differences between the batches tested.All positive control strains were perfectly grown.The e.Coli baa-2523 produced the expected colony appearance developing as spontaneous pink to burgundy coloration , producing beta-glucuronidase and beta-galactosidase.The klebsiella , enterobacter ( kesc strains ): produced the expected colony appearance developing as spontaneous bluish green to bluish gray coloration producing beta-glucosidase ( beta-glu).Moreover, there were no differences regarding numeration, colony size and color, despite that some batches were more fresh (6 and 7 weeks) than the complaint batch ( inoculation near to its expiration time), thereby, the findings were expected and within acceptance criteria, and as identified in the qc test.The customer strains were tested but at the time the complaint batch was expired.The strains were tested as the internal qc strains with the same retention samples in order to verify if along the shelf life of the product the sensitivity could have variability.The batches tested with customer strains were: 1005489660 tested immediately after manufacturing; 1005541383 tested 6 weeks after manufacturing; 1005346540 tested 11 weeks after manufacturing; 1005343440 tested 11 weeks after manufacturing (complaint batch).After 24 hours of incubation we can observe that: ·e.Coli 0185 and e.Coli 234, growth poorly at 24 and also at 48 hours.·e.Coli 225: growth poorly at 24 hours but conform at 48 hours.·e.Coli 222 ,235 and 193: total inhibition at 24 and 48 hours.The problem does not appear to be linked with the chromid carba smart batches, as all present the same results and the qc strains performed as expected.The customer's six strains were confirmed to be oxa-48 (pcr oxa-48 like positive) with additional confirmation that the chromid carba smart performed correctly.On the carb part of the biplate, the no growth of these strains (type oxa-48) is possible according to the product limitation.On the oxa part of the biplate, the customer issue was duplicated in-house (weak growth or no growth): lack of sensibility of chrom id carba smart medium, probably due to the atypical susceptibility to some drugs present in the medium.The investigation concluded that the problem was due to lower cmi of these strains to the antibiotic included in the media.As media concentration is higher, it is normal to see the results observed by customer and confirmed by manufacturing site.In packet insert it is defined that the performance of this media was evaluated at a national center for detection of antimicrobial resistance using human clinical specimens.Sensitivity was evaluated using 54 oxa-48 carbapenemase producing enterobacteriacea and sensitivity obtained was around 95%.It is not mentioned that 100% of sensitivity observed with a customer strain could be related with the product limitations.Sensibility of the medium has been fixed on 95%, and it is possible therefore, that some strains oxa positive are not detected in this medium.The investigation concluded that the problem was due to lower cmi of these strains to the antibiotic included in the media.As media concentration is higher, it is normal to see the results observed by customer and confirmed by manufacturing site.

• Brand Name: CHROMID CARBA SMART
• Type of Device: CHROMID¿ CARBA SMART
• Manufacturer (Section D): BIOMÉRIEUX S.A.; 5, rue des aqueducs; craponne, fr 69290; FR
• Manufacturer (Section G): BIOMÉRIEUX S.A.; 5, rue des aqueducs; craponne, fr 69290; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6335917
• MDR Text Key: 68130988
• Report Number: 3002769706-2017-00030
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2017
• Device Catalogue Number: 414685
• Device Lot Number: 1005343440
• Other Device ID Number: 03573026423506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1