MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA SMART AGAR

Catalog Number 413050

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomerieux (b)(6) colonies growing on chromid¿rsa smart (lot 1005600120).The customer reported that one (b)(6) plate inoculated with a nasal swab from one patient, had (b)(6) colonies growing on it.The colonies were pink-red after 24 hour incubation and were sub-cultured onto ba plates and tested again, showing it was (b)(6).The customer did not perform qc on receipt of the shipment and all plates were used for testing.The customer stated a presumptive (b)(6) result was reported, then there was a delay of two days as they repeated the sensitivities to be sure there was only the (b)(6) present.It was not known if patient treatment was impacted.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieuxinternal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported to biomerieux (b)(6) colonies growing on one plate of chromid® mrsa smart (lot 1005600120).The customer could not provide the strains for the investigation.An investigation was performed.No other complaints were registered for chromid® mrsa smart (lot 1005600120).It was not possible to investigate the retained lot because at the time when the investigation was opened, the lot was expired.Manufacturing batch records were reviewed: one pool of mrsa smart atb additive and one pool of mrsa smart substrate additive were used in the manufacturing of the product.The quality control testing for the weight of the product conformed with specification for the whole duration of the manufacturing process.The quality control for the lot conformed with specifications as indicated in the quality certificate.There were no non-conformance's detected during the manufacturing of the two lots.In conclusion, chromid® mrsa smart (lot 1005600120) met manufacturing specifications.Without the return of the strain, it was not possible to further investigate the issue.

• Brand Name: CHROMID® MRSA SMART AGAR
• Type of Device: CHROMID® MRSA SMART AGAR
• 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: 6688298
• MDR Text Key: 79256576
• Report Number: 3002769706-2017-00155
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091024
• 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: 11/13/2017

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: 06/07/2017
• Device Catalogue Number: 413050
• Device Lot Number: 1005600120
• Other Device ID Number: 03573026390808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1