MAUDE Adverse Event Report: BIOMÉRIEUX ESPAÑA CHROMID® MRSA AGAR

Catalog Number 43459

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported (b)(6) results in association with the chromid tm mrsa agar ( (b)(4), lot 1004074290, expiry 27aug15).The customer indicated the bacteria growth appeared green (resistant) on the chromid mrsa agar.However, the strain was confirmed to be (b)(6) (susceptible) using a (b)(6) screening test, vitek 2 and cefoxitin disc diffusion.The customer claims minimal delay (<24 hours) for the confirmation test results, and that the discrepant chromid mrsa result was not reported to the physician.Customer qc for the incriminated lot provided results in accordance with specification.Sop 029481, 4.2.4 § erroneous ast, states that a(b)(6) result is considered as serious because inappropriate treatment could be provided leading to treatment failure.(b)(4), § principle, states there is detection of mrsa strains by revealing green colonies.It should be noted that within the ifu, in the summary and explanation paragraph , there is a cautionary note stating this medium does not replace conventional antimicrobial susceptibility tests.There is no indication or report from the hospital or treating physician to biomedieux that the discrepant chromid mrsa result led to any adverse event related to the patient's state of health.Strain submittals have been requested from the customer.Biomedieux internal investigation has been initiated.

• Brand Name: CHROMID® MRSA AGAR
• Type of Device: CHROMID® MRSA AGAR
• Manufacturer (Section D): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, spain 28760 ; SP 28760
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5027788
• MDR Text Key: 25502096
• Report Number: 3002769706-2015-00076
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 07/17/2015

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: 08/27/2015
• Device Catalogue Number: 43459
• Device Lot Number: 1004074290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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