STATSPIN MP X00-003917-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-29 for STATSPIN MP X00-003917-001 manufactured by Iris Diagnostics.

Event Text Entries

[4876845] Customer reported the centrifuge rotor broke apart.
Patient Sequence No: 1, Text Type: D, B5

[11993420] It was reported that a rotor broke apart, but the contents were contained within the centrifuge. No one was exposed or had to be treated. No injuries or loss of patient samples were reported.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2023446-2014-00095
• MDR Report Key: 4030386
• Report Source: 05,06
• Date Received: 2014-07-29
• Date of Report: 2014-06-06
• Date of Event: 2014-06-06
• Date Mfgr Received: 2014-06-06
• Device Manufacturer Date: 2004-04-01
• Date Added to Maude: 2014-09-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SUDHA GUPTA
• Manufacturer Street: 9172 ETON AVE.
• Manufacturer City: CHATSWORTH CA 91311
• Manufacturer Country: US
• Manufacturer Postal: 91311
• Manufacturer Phone: 8185277272
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STATSPIN MP
• Generic Name: STATSPIN CENTRIFUGE
• Product Code: GKG
• Date Received: 2014-07-29
• Catalog Number: X00-003917-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IRIS DIAGNOSTICS
• Manufacturer Address: 9172 ETON AVE. CHATSWORTH CA 91311 US 91311

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-29