MAUDE Adverse Event Report: BIOMÉRIEUX, SA CHROMID® CPS® ELITE

Catalog Number 418284

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: isolation, enumeration, and direct or presumptive identification of urinary tract infection organisms.This medium is an isolation, enumeration, and identification medium for urine specimens.This medium enables: the microbial enumeration of the specimen by means of standardized inoculation methods.The direct identification of escherichia coli.The presumptive identification of the following bacterial species or genera: enterococcus; klebsiella, enterobacter, serratia, citrobacter (kesc); proteus, morganella, providencia (pmp).Description: a customer in colombia notified biomérieux of obtaining incorrect colony coloration for escherichia coli in association with the chromid® cps elite 20 plt trans (ref 418284, lot 1009311370).The customer provided photos of what appears to be blue/green colonies, while escherichia coli should produce red to burgundy colonies.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of obtaining incorrect colony coloration for escherichia coli in association with the chromid® cps elite 20 plt trans (ref 418284, lot 1009311370).Investigation: complaint trend analysis: global customer service (gcs) performed a complaint trend analysis.Only this particular complaint has been received for chromid® cps elite 20 plt trans (ref 418284, lot 1009311370).The customer's issue has also not been identified as a trend for the product.Manufacturing record review: lot number 1009311370 was manufactured on 04apr2022 and (b)(4) kits were released with an expiry date of 31jul2022.All the manufacturing data for this lot number was reviewed, such as, the preparation of the media, the filling step, weight and appearance controls and all the parameters were within specifications.In order to release the product, technical laboratory quality controls were performed on samples that were manufactured at different manufacturing times.The samples were tested for the product's appearance, ph , microbiology state and microbiological activity.All the controls performed complied with specifications.Biomérieux did not observe any performance issue, sensitivity and/or specificity, for this product.The recovery rate for all positive controls were within specifications, notably for the following strains: escherichia coli atcc 25922: good growth with burgundy colonies.Escherichia coli 9909604 (gur neg): good growth with burgundy colonies.There were no nonconformances linked with manufacturing and/or any type of observation that could explain the issue that the customer reported.Customer sample analysis: the customer did not provide the strain for investigational testing.Retained sample analysis: biomérieux retains samples of every lot number released to the market.As the impacted lot number had already expired at the time of the investigation, it was not possible to test retained samples from the lot in question.Root cause: a cause for the customer's issue could not be determined and the issue could not be reproduced internally since the strain was unable to be provided for additional testing.The customer's strain may be atypical.Conclusion: the investigation did not identify any performance issue related to the chromid® cps elite 20 plt trans (ref 418284, lot 1009311370).

• Brand Name: CHROMID® CPS® ELITE
• Type of Device: CHROMID® CPS® ELITE
• Manufacturer (Section D): BIOMÉRIEUX, SA; 6, c de isaac newton; tres cantos; madrid 28760 ; SP 28760
• Manufacturer (Section G): BIOMÉRIEUX, SA; 6, c de isaac newton; tres cantos; madrid 28760 ; SP 28760
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15249144
• MDR Text Key: 305520809
• Report Number: 3009307598-2022-00004
• Device Sequence Number: 1
• Product Code: JXA
• UDI-Device Identifier: 03573026468828
• UDI-Public: 03573026468828
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 418284
• Device Lot Number: 1009311370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1