MAUDE Adverse Event Report: 3M; BIOLOGICAL INDICATOR SYSTEM

Model Number 290

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Bio test alarmed just shy of 3 hour test time indicating culture grew or positive failure to sterilize.However, the next day it was discovered it tested negative.Original test was false positive.Pt received unnecessary dose of antibiotic with anticipating exposure of unsterile equipment based on false positive.

• Type of Device: BIOLOGICAL INDICATOR SYSTEM
• Manufacturer (Section D): 3M; st. paul MN 55144
• MDR Report Key: 4295026
• MDR Text Key: 5054244
• Report Number: MW5039316
• Device Sequence Number: 1
• Product Code: FRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/24/2014

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 Model Number: 290
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR