MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN MP; STATSPIN CENTRIFUGE

Catalog Number X00-003917-001

Device Problems Mechanical Problem (1384); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

Customer reported the unit was not spinning well.

Manufacturer Narrative

Inadequate spinning of samples was reported for the centrifuge.Customer had to spin multiple times to separate the tubes.No change to pt management or erroneous results were generated.

• Brand Name: STATSPIN MP
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4102704
• MDR Text Key: 21494288
• Report Number: 2023446-2014-00139
• Device Sequence Number: 1
• Product Code: GKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-003917-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1