CELL-DYN SMS 05H29-04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-18 for CELL-DYN SMS 05H29-04 manufactured by Abbott Diagnostics Division.

MAUDE Entry Details

• Report Number: 2919069-2019-00074
• MDR Report Key: 8707658
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-06-18
• Date of Report: 2019-09-16
• Date of Event: 2019-05-30
• Date Mfgr Received: 2019-09-11
• Device Manufacturer Date: 2008-11-12
• Date Added to Maude: 2019-06-18
• 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: CHRISTIAN LEE
• Manufacturer Street: 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
• Manufacturer City: ABBOTT PARK IL 600643537
• Manufacturer Country: US
• Manufacturer Postal: 600643537
• Manufacturer Phone: 224668-294
• Manufacturer G1: ABBOTT DIAGNOSTICS DIVISION
• Manufacturer Street: 4551 GREAT AMERICA PARKWAY
• Manufacturer City: SANTA CLARA CA 95054
• Manufacturer Country: US
• Manufacturer Postal Code: 95054
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CELL-DYN SMS
• Generic Name: AUTOMATED BLOOD FILM PREPARATION AND STAINING
• Product Code: GKJ
• Date Received: 2019-06-18
• Catalog Number: 05H29-04
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT DIAGNOSTICS DIVISION
• Manufacturer Address: 4551 GREAT AMERICA PARKWAY SANTA CLARA CA 95054 US 95054

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-18