MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Model Number	08H00-03
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported the cell-dyn sapphire power cord from the outlet is melted at the connection to the back of the ups.The customer reported the instrument made a beeping sound and the technician reported a plastic odor, after which they unplugged the cord.No injury was reported.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation of the customer issue included a review of the complaint text, a review of historical data, a review of trending data, consultation with field service engineer (fse), and a review of product labeling.A review of historical data did not identify any product issues related to the complaint incident.No trends were identified.The fse could not rule out the possibility if additional devices were plugged into this ups which could have caused the ups to be overloaded.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 9688923
• Report Number: 2919069-2020-00004
• Device Sequence Number: 3341118
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08H00-03
• Device Catalogue Number: 08H00-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1