MAUDE Adverse Event Report: BD BD MAX MRSA ASSAY

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Death (1802)

Event Date 02/21/2015

Event Type  Death  

Event Description

Our institution uses a bd max mrsa assay for nasal swab specimens and positive blood cultures with gram positive cocci in clusters.Pt was admitted for a low hemoglobin on (b)(6).Pt was eventually found to have a hemothorax and transferred to the icu on (b)(6).Pt spiked fevers on (b)(6) and blood cultures were obtained that turned positive later that day.Gram stain of blood culture showed gram positive cocci in clusters.The specimen was run on the bd max (b)(4) assay.The assay suggested (b)(6).The icu team switched the pt from vancomycin to nafcillin.Traditional culture and sensitivity later revealed (b)(6).The pt is now under hospice care.

• Brand Name: BD MAX MRSA ASSAY
• Type of Device: BD MAX MRSA ASSAY
• Manufacturer (Section D): BD
• MDR Report Key: 4569664
• MDR Text Key: 21451348
• Report Number: MW5041071
• Device Sequence Number: 1
• Product Code: NQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 81