MAUDE Adverse Event Report: BECKMAN COULTER ACCESS 2 IMMUNOASSAY SYSTEM

Model Number ACCESS 2 IMMUNOASSAY SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/26/2015

Event Type  No Answer Provided  

Event Description

The beckman coulter chemistry instrument failed as a result of play between shaft and rotor head.The vendor is responsible for all major maintenance and repairs on instrument.As a result of the manufacturing parts, critical results were reported on patient in the ed.The patient received treatment based on the critical reports released.Same report as mw5044161-mw5044162.

• Brand Name: ACCESS 2 IMMUNOASSAY SYSTEM
• Type of Device: ACCESS 2 IMMUNOASSAY SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; WV
• MDR Report Key: 4916280
• MDR Text Key: 6051078
• Report Number: MW5044163
• Device Sequence Number: 1
• Product Code: MMI
• 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: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACCESS 2 IMMUNOASSAY SYSTEM
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR