MAUDE Adverse Event Report: BIOMÉRIEUX SA GELOSE CHROMID CPS ELITE AGAR

Catalog Number 421151

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

Product intended use: chromid® cps® elite agar is an isolation, enumeration and identification medium for urine specimens.It enables: the microbial enumeration of the specimen by means of standardized inoculation methods.The direct identification of escherichia coli and the presumptive identification of the following bacterial species or genera: enterococcus, klebsiella, enterobacter, serratia, citrobacter (kesc), proteus, providencia, morganella (proteeae).Description of the issue: a customer from (b)(6) reported that he observed contamination after use when using chromid® cps® elite agar (ref.(b)(4)) ¿ lot 1008598280.The customer reported contamination on 35 plates from the same lot number.The customer seeded samples on eight (8) plates among the 35 contaminated.He reported that he had not observed contamination before seeding.The customer reported that most of the contamination was from colonies of bacteria, with two-to-three plates showing fungi.The number of patients associated with the eight (8) plates was not specified by the customer.The customer reported that the eight (8) samples had to be reseeded, leading to a 24-hour delay in releasing the patient¿s result.There is no indication or report from the laboratory that the delayed results led to any adverse event related to any patient's state of health.

Manufacturer Narrative

Context: an investigation was initiated following a complaint on the product chromid® cps® elite agar, reference 421151, lot 1008598280, expiry date 08 july 2021, for contaminated plates observed after use.The customer mentioned that eight (8) samples had to be re-inoculated and there was a 24-hour delay in releasing the result.Contamination was not noted before use of the product.The total number of plates reported to be contaminated is thirty-five (35).The customer mentioned that most of the contamination was colonies of bacteria and that two-to-three plates had fungi.Investigation: **lot number record analysis** chromid® cps® elite agar, reference 421151, lot 1008598280 was manufactured on 11 march 2021 and a total of 96,220 plates were released with an expiry date of 08 july 2021.Quality control tests were performed in order to release these products.The results obtained were within specifications and the lot was released in accordance with product specifications.**retained samples analysis** biomérieux retains samples of every lot number released to the market.We investigated the retained samples for the impacted lot: 1008598280.Testing was performed in order to verify if the impacted lot number was in accordance with our quality control specifications.The impacted lot was retested for the sterility test, sample plates were incubated at 35ºc ±2ºc and 23ºc ±2ºc from the 19 may 2021 to 26 may 2021.The result obtained after incubation were in accordance with specifications.We did not observe any contamination on retained sample plates either before or after incubation.Complaint trend analysis apart from the current complaint, no other complaints were registered on this lot number.Conclusion: the lot number record analysis indicated that the impacted product chromid® cps® elite agar, reference 421151, lot 1008598280, expiry date 08 july 2021, complies with specifications.The sterility quality control test on the retained biomérieux samples was within specification for the impacted lot number.We did not reproduce the problem observed by the customer during our investigation.This reference is not an irradiated product, thus there is a possibility that contamination may occur.The package insert therefore mentions not to use contaminated plates.As the performance of the impacted lot is within specifications and as this investigation did not reproduce the problem observed by the customer, neither corrective nor preventive actions will be implemented.

• Brand Name: GELOSE CHROMID CPS ELITE AGAR
• Type of Device: GELOSE CHROMID CPS ELITE AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11894732
• MDR Text Key: 267836821
• Report Number: 9615755-2021-00008
• Device Sequence Number: 1
• Product Code: JXA
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: 421151
• Device Lot Number: 1008598280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1