MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® CPS ELITE

Catalog Number	418284
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported no growth (false negative) of an escherichia coli strain from a patient urine sample, in association with the chromid® cps elite agar (lot 1007058530).The sample was from a (b)(6) year old patient with no antibiotic therapy and inflammatory syndrome and leukocytosis.The customer stated there was no growth on the chromid cps elite agar, but growth was observed on cos + polyvitex agar.The strain was then identified as escherichia coli by vitek® 2.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.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for no growth (false negative) of an escherichia coli strain from a patient urine sample, in association with the chromid® cps elite agar (lot 1007058530).A review of quality records confirmed there was no issue with the manufacturing of chromid cps elite agar (lot 1007058530).The lot passed qc performance testing and met release criteria.A review of complaints registered for the impacted lot number 1007058530 indicated there is no other complaint.Trend analysis performed from 01jan2015 to 04jun2019 for this product reference regarding a false negative issue, did not detect a significant trend.Three chromid cps elite retains were inoculated with internal positive quality control strains in parallel with other batches.After incubation at 33-37°c during 18-24 hours, specificity and sensitivity were equivalent between all batches tested.The specificity of identification to e.Coli according to the color and morphology of the colonies, was excellent for the customer's lot.The e.Coli strains tested produced the expected colony appearance, spontaneous red to burgundy coloration, in agreement with the acceptance criteria and equivalent to the initial qc tests.The customer's patient strain was inoculated on chromid cps elite in parallel with other lot numbers.The initial inoculation showed growth of brownish colonies instead of the expected pink to burgundy color characteristic of e.Coli.A swarming surrounding the colonies was also visible.Therefore, the clinical strain looked like a proteus spp on all plates tested.The clinical sample was subcultured again and two different types of colonies were observed; major growth of brown colonies presumptive of proteae mixed with typical pink -burgundy colonies characteristic of e.Coli.Both types of strains were identified using the vitek 2 system which confirmed the presence of e.Coli (97%) and p.Mirabilis (98%).The customer's false negative result was not reproduced.In conclusion, the quality control tests performed did not highlight a deviation in the quality of the product.The tests performed on the clinical strain received, showed a mixed culture of escherichia coli and proteus mirabilis.Both strains gave expected results on chromid cps elite agar.According these results the probable root cause is linked to the presence of mixed flora coming from the urine specimen.Swarming properties of proteus mirabilis when mixed growth is present could hide the growth and color of other strains such as e.Coli.Chromid cps elite agar (lot 1007058530) performed as expected.

• Brand Name: CHROMID® CPS ELITE
• Common Device Name: CHROMID® CPS ELITE
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 8458030
• Report Number: 9615755-2019-00003
• Device Sequence Number: 10818523
• Product Code: JXA
• UDI-Device Identifier: 03573026468828
• UDI-Public: 03573026468828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 05/13/2019
• Device Catalogue Number: 418284
• Device Lot Number: 1007058530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1