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

Catalog Number	416172
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of contamination with acinetobacter nosocomialis in association with chromid® cps elite 100 pl trans (ref.416172, lot: 1008224320) while testing four separate patient samples.The customer cultured three (3) separate urine isolates and one (1) subphrenic puncture fluid isolate using lot: 1008224320.Biomerieux customer service advised that chromid® cps elite 100 pl trans ref.416172 is for validated the testing of urine samples only and that testing of other sample types is considered off label use.The isolates were then tested using the vitek® ms; all isolates were identified as acinetobacter nosocomialis.The customer stated the result of acinetobacter nosocomialis was atypical.Additionally, the customer stated their previ® isola comb traced a contaminant on the perimeter of the three urine isolate plates.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed following customer notification from two french customers of contamination with acinetobacter nosocomialis in association with chromid® cps elite 100 pl trans (ref.416172, lot 1008224320).The investigation reviewed the production and release records for the lot in question.No anomalies were noted during the manufacturing process.Before releasing the plates, quality control tests were performed using samples from various points within the process.All results met release criteria for distribution.The investigation observed retained samples of the impacted lot for evidence of contamination.Upon opening of the retained plate kits, no contamination was visible.The retained samples were then incubated for five days in aerobic conditions at 33-37°c.Plates were examined each day to check for any growth.After five days of incubation, contamination was not observed.The contamination reported by the customer was not reproduced on the retained samples.The customers reporting this issue returned a total of 700 plates to be used in the investigation.The plates arrived in closed plastic packs with 10 plates each.Thirty-four plates were discarded due to breakage that occurred during transport.From the remaining plates, 666 plates, seven were found to be contaminated upon opening of the plastic packaging.There was a single brown-ish colony on each.The colonies were identified as acinetobacter baumanii complex by the vitek® 2 system.The manufacturing times for these seven plates were between 11hours 10minutes and 11hours 21minutes.This contamination must have occurred during manufacturing as the contaminated plates were still sealed within their plastic packaging.None of the other plates (659) presented any contamination before use.They were incubated under aerobic conditions at 33-37°c for five days and checked each day.No other contamination was observed on the remaining plates.The customer¿s contamination after incubation issue was not reproduced.Trend analysis revealed only these two customer reports of contamination for lot#1008224320.In conclusion, the bacterial contamination after use was not reproduced on retained sample plates nor returned plates.Contamination before use was confirmed with the same type of bacterium found at the customer¿s site and during investigation (acinetobacter baumanii complex/nosocomialis).However, data from the investigation indicates a low level of contamination during manufacturing as only one colony was observed on seven out of 666 plates provided for the investigation.This contamination occurred over a short period of time as the impacted manufacturing times were between 11h06 and 11h31 (manufactured 05-aug-2020).Furthermore, at the time that this impacted lot was manufactured, the environmental control data indicated that all the controls were within specifications.The levels of contamination by acinetobacter in the production areas will be monitored.The probability of harm was assessed by biomerieux to be improbable.The customers were reminded to follow guidance in the instructions for use for product chromid® cps® agar (cpse), reference 416172: ¿do not use plates that are contaminated.¿.

• 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: 10687625
• Report Number: 9615755-2020-00025
• Device Sequence Number: 571768
• 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): 11/17/2020

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: 12/01/2020
• Device Catalogue Number: 416172
• Device Lot Number: 1008224320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1