MAUDE Adverse Event Report: BIOMÉRIEUX, SA CHROMID CPS ELITE 100 PL TRANS

Catalog Number	416172
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: chromid® cps® elite agar is an isolation, enumeration and identification medium for urine specimens.Issue description: a customer in (b)(6) notified biomerieux of microbial contamination in association with the chromid® cps® elite agar (ref.416172, lot 1008840600).The customer observed microbial contamination of large glossy beige colonies on lot 1008840600.The contaminant was identified as acinetobacter nosocomialis using the maldi-tof test method.The customer confirmed two (2) contaminated plates were used to culture urine isolates from two separate patients.There is no adverse event to either patient's state of health; it was confirmed the contaminant was observed and new urine subcultures were performed.Biomérieux has initiated an internal investigation.
Additional Manufacturer Narrative
A customer in france notified biomérieux that they observed what appeared to be microbial contamination (post sample inoculation) in association with the chromid® cps® elite agar (ref.(b)(4), lot 1008840600).They sent pictures of large, opaque, glossy, beige colonies on the surface of the plates (3-4 colonies per plate, sometimes in traces).Exudation was not observed on the product.Customer estimated that roughly 10% of 67 kits are impacted by the issue.The organism was identified by the site as acinetobacter nosocomialis (photos were provided).Investigation lot number 1008840600, reference (b)(4), was manufactured on 12-july 2021 and 794 kits were released with an expiry date of 07-november-2021.The quality control tests, such as macroscopic appearance, ph measurements, microbiological performance and microbiological state, that were performed prior to releasing this lot number were within specifications.The investigator did not find evidence of any contamination on the plates tested.The number of plates tested is in accordance with the sampling plan based on standards.The customer¿s lot complied with specifications and non-conformances were not recorded on this lot.A review of biomérieux complaints database indicated that apart from this report, no other complaints were registered on this lot (1008840600).Retained sample analysis: the investigator tested retained sample plates from the impacted lot number (1008840600) that were pulled during manufacture at various times in the process.Removing the retained sample plates from storage at 2-8°c, contamination was not detected on any plates observed.Next the complaints laboratory incubated the retained sample plates at 33-37 °c.No contamination was observed after 24 hours.Plates where then checked every 24 hours for five days of incubation; no colony or contamination growth was seen.Biomérieux was unable to confirm the issue reported.This product is not an irradiated product, therefore the possibility exists that contamination can occur during the manufacturing process.Conclusion: the lot number record analysis indicated that the impacted lot 1008840600 complied with our specifications and non-conformances were not recorded on this lot.Additionally, no other customers have reported issues with this lot of plates.Biomérieux is unable to confirm the customer report.

• Brand Name: CHROMID CPS ELITE 100 PL TRANS
• Common Device Name: CHROMID CPS ELITE 100 PL TRANS
• Manufacturer (Section D): BIOMÉRIEUX, SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 12527598
• Report Number: 9615755-2021-00009
• Device Sequence Number: 5146452
• Product Code: JXA
• UDI-Device Identifier: 03573026443900
• UDI-Public: 03573026443900
• 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): 11/01/2021

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: 11/07/2021
• Device Catalogue Number: 416172
• Device Lot Number: 1008840600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1