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

Catalog Number	416172
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of a contamination after use in association with the chromid® cps elite agar (ref.416172, lot 1007747790) when testing two separate patient urine samples.The customer observed contamination on thirty (30) plates from four (4) boxes of lot 1007747790.The customer noted two contaminated plates had already been used to test two (2) separate patient urine samples.The contamination was observed after incubation.The contaminant on both plates was a large cream-colored mucous colony; brucker maldi-tof identified the contaminant as pseudomonas.The customer confirmed both contaminated patient sample plates were discarded and the results were not reported to the treating physician.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
On 07-apr -2020 it was realized that section g4 date received by mfg of report 9615755-2020-00003-01 was incorrectly marked as 03-mar-2020.The corrected date for section g4 is 04-mar-2020.
Additional Manufacturer Narrative
A customer from france notified biomérieux of a contamination after use in association with the chromid® cps elite agar (ref.416172, lot 1007747790) when testing two separate patient urine samples.The customer observed contamination on thirty (30) plates from four (4) boxes of lot 1007747790.The customer noted two contaminated plates had already been used to test two (2) separate patient urine samples.The contamination was observed after incubation.In response to the customer complaint biomérieux completed an internal investigation that included a review of production records, review complaints, and testing of product retains for lot 1007747790.Review of production records showed lot 1007747790 obtained passing quality control test results, including passing results for microbiological performance and microbiological state prior to batch release.A review of complaint data for lot 1007747790 did not identify any trends.Four (4) retained cellophane packets each with ten (10) plates from different manufacturing times were incubated 33-37 º c and examined for contamination every twenty four (24) hours.No contamination was observed across all plates.The contamination observed by the customer was not reproduced; however, the plates are not sterilized in the final manufacturing container, therefore contamination cannot be ruled out as a potential root cause.Chromid® cps elite agar lot 1007747790 met all qc release criteria and there is no evidence that suggests lot 1007747790 is not performing as intended.See section h10.

• Brand Name: CHROMID® CPS ELITE AGAR
• Common Device Name: CHROMID® CPS ELITE AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 9788781
• Report Number: 9615755-2020-00003
• Device Sequence Number: 2650342
• 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,Followup
• Report Date (Section B): 04/07/2020

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: 03/25/2020
• Device Catalogue Number: 416172
• Device Lot Number: 1007747790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 04/07/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/03/2020; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1