MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 360/560 DILUENT

Model Number	ADVIA 360/560 DILUENT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that the lab received containers of advia 360/560 diluent that were damaged during shipping.The customer was exposed to the diluent solution on their arms due to handling the damaged containers without personal protective equipment (ppe).As per the advia 560 hematology system operator's guide, when handling the advia 360/560 diluent, the operator must "wear protective gloves/protective clothing/eye protection/face protection." the customer was not wearing ppe at the time of the event.No further evaluation of this device is required.
Event or Problem Description
The customer received containers of advia 360/560 diluent that were damaged during transportation.The customer was exposed to the diluent solution on their arms and was not wearing personal protective equipment.The customer was not injured due to exposure to the diluent and did not seek medical attention.The damaged containers of diluent were discarded.There are no reports of medical intervention or adverse health consequences due to the customer's skin being exposed to the advia 360/560 diluent.

• Brand Name: ADVIA 360/560 DILUENT
• Common Device Name: ADVIA 360/560 DILUENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown 10591
• MDR Report Key: 9158095
• Report Number: 2432235-2019-00358
• Device Sequence Number: 2568134
• Product Code: GKZ
• UDI-Device Identifier: 00630414601274
• UDI-Public: 00630414601274
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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 Expiration Date: 03/31/2022
• Device Model Number: ADVIA 360/560 DILUENT
• Device Catalogue Number: 11170845
• Device Lot Number: 679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1