PICCOLO XPRESS CHEMISTRY ANALYZER 1100-0000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-02 for PICCOLO XPRESS CHEMISTRY ANALYZER 1100-0000 manufactured by Abaxis, Inc..

MAUDE Entry Details

• Report Number: 2939693-2020-00004
• MDR Report Key: 9541915
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-01-02
• Date of Report: 2020-01-02
• Date of Event: 2019-12-04
• Date Mfgr Received: 2019-12-04
• Device Manufacturer Date: 2013-11-13
• Date Added to Maude: 2020-01-02
• 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: 3
• Event Location: 3
• Manufacturer Contact: MS. RONI THEBO
• Manufacturer Street: 3240 WHIPPLE RD
• Manufacturer City: UNION CITY CA 94587
• Manufacturer Country: US
• Manufacturer Postal: 94587
• Manufacturer Phone: 2693599544
• Manufacturer G1: ABAXIS, INC.
• Manufacturer Street: 3240 WHIPPLE ROAD
• Manufacturer City: UNION CITY CA 94587
• Manufacturer Country: US
• Manufacturer Postal Code: 94587
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Removal Correction Number: 2939693-12/16/2019-001-R
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PICCOLO XPRESS CHEMISTRY ANALYZER
• Generic Name: PICCOLO ANALYZER
• Product Code: JJG
• Date Received: 2020-01-02
• Returned To Mfg: 2019-12-16
• Catalog Number: 1100-0000
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABAXIS, INC.
• Manufacturer Address: 3240 WHIPPLE ROAD UNION CITY CA 94587 US 94587

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-02