MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID CPS ELITE 100 PL TRANS

Catalog Number 416172

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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 biomérieux of microbial contamination in association with the chromid® cps® elite agar (ref.(b)(4), lot 1009188590).The customer observed microbial contamination of large glossy beige colonies on lot 1009188590.The contaminant was identified as bacillus cereus using the vitek® ms.The customer confirmed two (2) contaminated plates were used to culture urine isolates from two separate patients.The customer stated the observed contamination caused a delay of twenty-four hours as new subculture was required.However, the customer advised there is no adverse event to either patient's state of health; final subculture results were negative for both patients.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

Biomérieux conducted an internal investigation in response to a customer complaint of observed microbial contamination of bacillus cereus of the chromid® cps® elite agar (ref.(b)(4), lot 1009188590) following inoculation with two (2) separate urine isolates.Review of production records associated with lot 1009188590 found was manufactured on 25-january-2022 from 06h09 to 10h26.Two hundred and seventy three (273) kits of 100 plates each were released with an expiry date of 23-may-2022.The quality control (qc) of the weight and appearance of the product was checked during the manufacturing process and all the results complied with specifications.Prior to lot release, quality controls were performed on retained samples that were produced at different manufacturing times.The quality control tests performed were product appearance, ph, microbiology state and microbiological performance control.No anomalies were obtained for product appearance, ph and microbiological performance control.The microbiology state assay identified a discrepancy regarding the plates manufactured at 06h26.Microbial contamination was observed on three (3) plates with manufacturing time corresponding to the first retained samples (06h26).These plates were incubated four (4) days at 33-37°c and 20-25°c.The isolates were identified as bacillus spp.Using the vitek® 2 system.In response, a non-conformity record was opened and plates manufactured until 06h44 were rejected from release.A 5m methodology was used to determine the root cause of the contamination, environmental contamination was retained as root cause prior to 06h44.It was confirmed the customer¿s plates were manufactured at 07h57.The investigational testing of product retains was also performed, including plates manufactured at 07h57.The plates were visually inspected upon removal from storage, contamination was not observed.The retained plates were then incubated four (4) days at 33-37°c.The plates were negative for growth following the incubation.Biomérieux reviewed complaints associated with lot 1009188590.The review found one (1) complaint registered for a contamination by mold detected before use, indicating there is not a trend.Although the microbiology state assay found evidence of environmental contamination in plates manufactured at 06h26 prior to the release of lot 1009188590; it was confirmed all plates until 06h44 were rejected and not released.It was confirmed the customer¿s plates were manufactured at 07h57; the testing of these retains was negative.The contamination observed by the customer was not reproduced by biomérieux during investigation testing performed on lot 1009188590 retains.

• Brand Name: CHROMID CPS ELITE 100 PL TRANS
• Type of Device: CHROMID CPS ELITE 100 PL TRANS
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer (Section G): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer Contact: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13839675
• MDR Text Key: 287601201
• Report Number: 9615755-2022-00011
• Device Sequence Number: 1
• Product Code: JXA
• UDI-Device Identifier: 03573026443900
• UDI-Public: 03573026443900
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: 416172
• Device Lot Number: 1009188590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Date Device Manufactured: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1