MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

Model Number	ADVIA AUTOSLIDE SYSTEM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a slide was mislabeled with the incorrect sample id by an advia autoslide system.Siemens is investigating the issue.
Event or Problem Description
A slide made from a tube with sample id (b)(6) was mislabeled as sample id (b)(6) by an advia autoslide system.The manual differential count obtained for the mislabeled slide did not match the differential results obtained on an advia 2120i hematology system for sample id (b)(6).The discordant results were not reported to the physician(s).Two new slides were produced with the tube with sample id (b)(6), and the results matched the differential results obtained the advia 2120i hematology system.These correct results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the mislabeled slide.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2020-00010 on (b)(6) 2020.Additional information ((b)(6) 2020): a possible cause of the issue is that the advia autoslide timed out before the sample was aspirated by the advia autoslide but after the barcode was read by the advia 2120i hematology system.In this case the sample would be flagged in the slide log, prompting the user to take action.On the date of the event, the sample was flagged in the slide log.The cause of the slide being mislabeled could not be determined.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA AUTOSLIDE SYSTEM
• Common Device Name: ADVIA AUTOSLIDE SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 9569061
• Report Number: 2432235-2020-00010
• Device Sequence Number: 13888922
• Product Code: GKL
• UDI-Device Identifier: 00630414560595
• UDI-Public: 00630414560595
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: ADVIA AUTOSLIDE SYSTEM
• Device Catalogue Number: 10282177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1