MAUDE Adverse Event Report: IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC. STATSPIN EXPRESS 4; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Model Number STATSPIN EXPRESS 4

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2016

Event Type  malfunction  

Event Description

The centrifuge failed during spin.The metal support arm for the swing-bucket failed.

• Brand Name: STATSPIN EXPRESS 4
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC.; 9172 eton avenue; chatsworth CA 91311
• MDR Report Key: 5603266
• MDR Text Key: 43516603
• Report Number: 5603266
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016,04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STATSPIN EXPRESS 4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2016
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1