MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC EPLEX GRAM NEGATIVE BCID PANEL; GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS

Lot Number 53961068

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

Event Type  Death  

Event Description

Gram negative identification panel resulted as not detected for klebsiella oxytoca organism from culture plate /raoultella ornithinolytica.

• Brand Name: EPLEX GRAM NEGATIVE BCID PANEL
• Type of Device: GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS
• Manufacturer (Section D): GENMARK DIAGNOSTICS, INC
• MDR Report Key: 12099092
• MDR Text Key: 259609302
• Report Number: MW5102212
• Device Sequence Number: 1
• Product Code: PEN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2021

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: 09/23/2021
• Device Lot Number: 53961068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Weight: 74