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

Catalog Number 43861

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

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported false resistant results in association with chromid® carba agar (lot 1006576530).The customer performed cre (carbapenemase-resistant enterobacteriaceae) screening on the chromid agar and green colonies were grown.There were two size colonies (large and medium) and both were tested using vitek® 2 ast and etest®.[1] colony size : large (isolate 1, specimen 2144); vitek2 gn id : klebsiella pneeumoniae ssp pneumoniae; vitek2ast-n224 : ertapenem 4 r / imipenem 0.5* r*; e-test : ertapenem 0.5 s / imipenem 0.38 s.[2] colony size : medium (isolate 3, specimen 2144); vitek2 isolate number (b)(4); vitek2gn id : klebsiella pneeumoniae ssp pneumoniae; vitek2ast-n224 : ertapenem 2 r / imipenem 0.25* r*; e-test : ertapenem 0.5 s / imipenem 0.5 s.No patient information was provided by the customer.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.Later, the customer reported they lost isolates 1 and 3 of specimen 2144, and provided other strains for investigation.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer in korea reporting false resistant results in association with chromid® carba agar (lot 1006576530).The customer provided six strains for investigation.Lot number 1006576530 was manufactured on the 15-jun-2018 from 07h38 to 14h12 and 1815 kits were released with an expiry date of 30-aug-2018.The quality control of the weight and appearance of the product conformed with specifications for the duration of the manufacturing process.The quality control records confirmed the lot met he qc performance standards and release criteria.Analysis was performed on the retained sample plates for lot number 1006576530, expiry 30-august-2018, and on a reference lot number 1006724240, expiry 05-nov-2018.Testing was performed with atcc control strains to verify microbiological performance was in accordance with the quality control protocol for reference 43861.The results obtained on the impacted lot number and the reference lot number conformed with the expected described specifications.The six strains provide by the customer were identified and tested on a reference lot number 1006700920, expiry 23-oct-2018.The following results were obtained: strain identification: customer strain numbers: i - 2426, v - 2297: escherichia coli, customer strain numbers: ii - 2732 # strain 1, ii - 2732 # strain 2, iii - 2144, iv - 2319: klebsiella pneumoniae.The following results were obtained: after 24 hours of incubation, total inhibition was observed on all the customer strains except for number ii - 2732 # strain 1: klebsiella pneumoniae this customer strain was further tested using molecular testing: the in-house molecular characterization for carbapenemase genes obtained negative results using pcr methodology.Negative results on rapidec® carba were also obtained.Vitek 2 testing obtained a positive result for extended-spectrum beta-lactamase (esbl) on this strain.Complaint trend analysis was performed on the impacted lot number, and no other complaints were registered for this type of issue.Conclusion: the lot number record analysis indicated that the impacted lot number complies with specifications.Testing on the retained sample plates indicated that the product complied with described specifications.Complaint trending was performed and indicated that no other complaints were registered for this type of issue on the impacted lot numbers.The issue observed by the customer was confirmed on one strain provided for the investigation.Following further testing on the strain, it was determined that the strain was resistant to beta lactam.The fact that the impacted strain is not carbapenemase-producing enterobacteriaceae and is resistant to beta lactams, can explain growth on this medium during the shelf life of the product.In addition, the specificity of the media in terms of performance was evaluated to be 90.7%, as described in the package insert.The package insert states "some multi-resistant micro-organisms other than cpe may develop on the medium producing colonies with a typical color".The use of chromid¿ carba medium is for the screening of carbapenemase-producing enterobacteriaceae (cpe) and the package insert therefore states "in any case, carbapenemase production must be confirmed".The performance of the product is within specifications and the investigation did not identify a product performance issue.

• Brand Name: CHROMID® CARBA AGAR
• Type of Device: CHROMID® CARBA AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 7882374
• MDR Text Key: 120736743
• Report Number: 3002769706-2018-00185
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: 43861
• Device Lot Number: 1006576530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1