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

Model Number ADVIA 360/560 DILUENT

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

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 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
• Type of Device: ADVIA 360/560 DILUENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): DIATRON MI PIC; registration #: 3009297077; tablas str. 39; budapest, H-109 7; HU H-1097
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 9158095
• MDR Text Key: 196198864
• Report Number: 2432235-2019-00358
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601274
• UDI-Public: 00630414601274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1