MAUDE Adverse Event Report: CHROMID® CPS® ELITE AGAR

Catalog Number	418206
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
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).Issue description: a customer in france notified biomérieux of discrepant identification for an urine sample with e.Coli strain in association with chromid cps elite opaque 20 pt (ref.418206, lot unknown).The customer stated that he had discrepant results between : cpso and vitek® ms for an urine culture sample.Result summary: *cpso plate: showed blue colonies, indicating kesc (klebsiella, enterobacter, serratia and citrobacter).E.Coli should result in red to burgundy coloration.*vitek ms : e.Coli strain (identification 99.9%).The customer informed biomérieux customer service that no delay in the result and no patient impact were observed.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 has been initiated.
Additional Manufacturer Narrative
An internal investigation was performed following notification from a customer in france that they had an escherichia coli strain grown on chromid® cps® elite agar (cpso), {ref.418206, lot#1009015690) where the colonies were blue in color instead of red to burgundy.The customer provided a photograph and the strain in question for our investigation.Investigation.Batch record review.Lot number 1009015690 was manufactured on 15-october 2021 and (b)(4) kits were released with an expiry date of 10-february-2022.Manufacturing data for this lot number was reviewed and all parameters were within specifications.Retained samples the impacted lot number had already expired at the time of the investigation; thus retained samples could not be tested.Customer sample testing the patient strain in question was identified as escherichia coli with the vitek® 2 and tested on the following cpso lot numbers that were manufactured on different dates: - 1009294190, expiry date 20-july-2022; - 1009222230, expiry date 09-june-2022; - 1009120070, expiry date 07-april-2022.The following results were obtained after incubation at 33-37 ºc: - after 14 hours of incubation the patient strain produced green-turquoise colored colonies.At 24 hours of incubation there are two types of colored colonies; green and dark blue to violet.This escherichia coli strain did not develop characteristic red to burgundy colonies on all lot numbers tested.Biomérieux investigation reproduced the customer's result.Biochemical profiling of this patient strain shows the following: - the strain expresses -glucosidase enzymatic activity along with -galactosidase activity and does not express -glucuronidase activity.The enzymatic profile of this strain is atypical and explains why characteristic red to burgundy escherichia coli colored colonies do not develop for this strain.The package insert describes that for e.Coli, spontaneous red to burgundy coloration is observed for strains producing -glucuronidase and/or -galactosidase.This strain expresses -glucosidase activity that hydrolyzes the chromogenic substrate in the media; therefore, green and dark blue violet colored colonies develop.Complaint analysis as of the date of this investigation, no other complaints were registered on the impacted lot number (1009015690).Conclusion.Biochemical profiling of this strain shows that the strain expresses -glucosidase enzymatic activity along with -galactosidase activity and does not express -glucuronidase activity.The enzymatic profile of this strain is therefore atypical and explains why characteristic red to burgundy escherichia coli colored colonies do not develop for this strain.The package insert describes that for e.Coli, spontaneous red to burgundy coloration is observed for strains producing -glucuronidase and/or -galactosidase.This strain expresses -glucosidase activity that hydrolyzes the chromogenic substrate in the media therefore, green and dark blue violet colored colonies develop.

• Brand Name: CHROMID® CPS® ELITE AGAR
• Common Device Name: CHROMID® CPS® ELITE AGAR
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14019869
• Report Number: 3009307598-2022-00001
• Device Sequence Number: 4613375
• Product Code: JXA
• UDI-Device Identifier: 03573026468170
• UDI-Public: 03573026468170
• Combination Product (Y/N): N
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: 418206
• Device Lot Number: 1009015690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown