MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID CPS ELITE / COL CNA AGAR; CHROMID® CPS® ELITE / COL CNA AGAR

Catalog Number	418229
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A biomrieux internal investigation has been completed with the following results: the batch records for lot number 1008372870 were reviewed.The quality control of the weight and the aspect of the product was checked during the manufacturing process and all the results complied with specifications.Colorimetry controls were also tested during manufacturing of this lot number and all the controls complied with specifications.Sample plates were also tested for microbiological state and appearance.There were 70 plates incubated at 20-25c and 70 plates incubated at 33-37c for five (5) days.No contamination or appearance defects were detected on all plates tested.The customer's lot number 1008372870, reference 418229, complied with specifications for all quality controls tested.No contamination was noticed upon removing the retained sample plates from storage.The retained sample plates were incubated at 20-25 c and 33-37 c.No contamination was observed after four (4) days of incubation.Contamination before use and after incubation was not confirmed on retained sample plates.
Event or Problem Description
A customer from (b)(6) notified biomrieux of a contamination with bacteria on the multimedia chromid cps elite agar/columbia cna agar + 5% sheep blood plates  reference 418229  lot #1008372870.The customer first observed the contamination after local storage, and then checked the media after using it and noticed some contamination after use.The customer stated the contamination was inside the agar and on the surface.The identification of the bacteria is not known.The customer confirmed that no erroneous patient results or delayed results were reported due to the contamination.

• Brand Name: CHROMID CPS ELITE / COL CNA AGAR
• Common Device Name: CHROMID® CPS® ELITE / COL CNA AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11585876
• Report Number: 9615755-2021-00006
• Device Sequence Number: 3072053
• Product Code: JXA
• UDI-Device Identifier: 03573026468545
• UDI-Public: 03573026468545
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 03/29/2021

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: 01/06/2021
• Device Catalogue Number: 418229
• Device Lot Number: 1008372870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1