MAUDE Adverse Event Report: BECTON DICKINSON GMBH BBL CHROMAGAR MRSA II*; SEE H.10

Catalog Number 257434

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name: culture media, antimicrobial susceptibility test, excluding mueller hinton agar.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that while using bbl" chromagar" mrsa ii* (b)(6) results were obtained on patient samples.Repeat testing done with different media and the results were accurate.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation: it was reported that colonies of staph aureus appear to be white instead of pink.Complaint history review: the complaints trends were reviewed for a period covering 12 months.There were no confirmed complaints during that period on this product.Therefore, a trend could not be identified.Batch history record (bhr) review: the batch history review could not be performed as the batch number was not provided.Sample analysis: picture sample was not provided.As the batch number was not provided, a performance test with the retention samples could not be performed.However, as the shelf life of this product takes 10 weeks, the products which were produced within the last 10 weeks (02.November 2020 - 11.January 2021) were reviewed.As a release criteria, the performance of the products from that time frame were reviewed and no deviation could be detected.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our production process.No deviation could be found during the qc performance test.Investigation conclusion: based on the evaluation of the report and based on the qc test results, the complaint was not confirmed.A corrective and preventive action will not be implemented as a trend could not be identified.A definite root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that while using bbl¿ chromagar¿ mrsa ii* false negative results were obtained on patient samples.Repeat testing done with different media and the results were accurate.There was no report of patient impact.

• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• MDR Report Key: 11267416
• MDR Text Key: 258598063
• Report Number: 9680577-2021-00004
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K092767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 257434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1