MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® S. AUREUS

Catalog Number 43371

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the (b)(6) reported to biomérieux a result of no growth for a staphylococcus aureus (atcc® 29213) quality control strain (frozen pellet) in association with chromid® s.Aureus agar.The customer reported there were no blue colonies when the test was repeated multiple times on plates with the same lot number from two separate boxes.The customer stated their protocol for blood cultures which show gram positive cocci on gram film, and isolates which give equivocal reactions on staphaurex plus test, are plated onto chromid® s.Aureus agar with the qc strain as positive control and a negative control strain.The control strain is tested by staphaurex plus and on vitek® 2 to confirm identification.The staphylococcus aureus isolates which were plated out on the chromid® s.Aureus agar, and did not give blue colonies, have been identified as staphylococcus aureus on both the vitek® 2 and maldi-tof.The plates are incubated aerobically at 37°c for 16-24 hours and for a further 24 hours if necessary.The customer stated there was no delay in reporting.There was no patient involvement as this was a quality control strain.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: as part of this investigation, biomérieux reviewed all raw data regarding manufacturing process and qc step all data is inside specifications and there are no nonconformities and/or observations that could explain the performance problem reported by the customer.Qc results were as expected and within current specifications, it should be noted that s.Aureus atcc 29213 was not tested in the initial control, therefore, as part of this investigation, this was tested on the complaint batch.Biomérieux performed a comparison of chromid s.Aureus with s.Aureus atcc 29213 following the qc standard procedure.Likewise, retention samples were tested in parallel with other batches manufactured at different times from the manufacturing date, in order to check the impact of the shelf life to the problem.It is important to note that the worst case conditions were tested because the medium expired as of 25may2017.Columbia blood agar was used as the control to make sure the recovery of all target strains were intended.After 18-24 hours at 33-37ºc, the performance was perfect, without differences among all batches tested , that is, numeration, size and sensitivity of identifying s.Aureus atcc 29213 (not tested at the time of the release), according to the color and morphology of the colonies, was excellent.The expected colony appearance was produced developing as spontaneous green coloration of colonies producing [?]-glucosidase.In conclusion, there is no observation and/or deviation regarding this batch, thereby; root cause cannot be identified at manufacturing level.No additional complaints have been received for this batch.Findings in the retention samples, confirming the chromogenic substrates were included in the medium, indicated s.Aureus atcc 29213 growth was within specifications and the enzymatic reaction was as expected, showing a good growth with the typical green colonies after 24 hours of incubation.Therefore, the results reported by the customer (absence of coloration) were not reproduced.Considering the customer complaint, root cause could be media deterioration but not related to the manufacturing process, but perhaps due to the length of exposure to light considering this media is very sensitive to the light exposure.Moreover, it should be noted that said, in accordance to the package insert, must not be exposed to light other than during the inoculation and reading step so this media is not compatible with 8 hours of light exposure.

• Brand Name: CHROMID® S. AUREUS
• Type of Device: CHROMID® S. AUREUS
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6581304
• MDR Text Key: 75628627
• Report Number: 3002769706-2017-00159
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2017
• Device Catalogue Number: 43371
• Device Lot Number: 1005474980
• Other Device ID Number: 03573026074999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1