MAUDE Adverse Event Report: DIMENSION SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO BY SIEMENS

Model Number APTIO BY SIEMENS

Device Problem Mechanical Problem (1384)

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

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center to report the aliquoter module on the aptio by siemens automation system was continuously attempting to load secondary tubes and not processing primary sample tubes causing a delay in routine patient testing.The aliquoter module did not generate an error message.Nine patient sample tubes were discarded and new samples were drawn.A siemens customer service engineer (cse) was dispatched to the site to inspect the instrument.A defective sensor in the aliquoter module was identifed and replaced.The cause of the delay in testing was a defective sensor in the aliquoter module.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer contacted the siemens customer care center to report an issue with the aliquoter module on an aptio by siemens automation system.Patient sample testing was delayed for several hours by the issue.Nine patient samples were not processed during the delay.The samples were discarded and new samples were drawn and processed.There are no known reports of patient intervention or adverse health consequences due to the delay in testing.

• Brand Name: APTIO BY SIEMENS
• Type of Device: APTIO BY SIEMENS
• Manufacturer (Section D): DIMENSION SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; italy registration #: 30055092; 10040 val della torre (torino), ; IT
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 8241465
• MDR Text Key: 133390563
• Report Number: 2517506-2019-00020
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2019

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 Model Number: APTIO BY SIEMENS
• Device Catalogue Number: 10703031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/11/2019
• 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