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

Model Number	APTIO BY SIEMENS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report that a low creatinine (cre) test result was obtained on an aliquot from the primary sample tube on an aptio by siemens system.The customer found water in the aliquoter secondary tube on the aptio input/output module.The customer turned off the aliqoter.A siemens customer service engineer (cse) was dispatched to the site to inspect the system.The cse replaced a pipetter valve and pump.The cause of the low creatinine test result was the pipette valve and pump.The instrument is performing according to specifications.No further evaluation of this instrument is required.
Event or Problem Description
A low creatinine (cre) test result was obtained on an aliquot from the primary sample tube on an aptio by siemens system.The initial result was reported to the physician(s).The primary sample was repeated and the repeat test result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the low creatinine test result.

• Brand Name: APTIO BY SIEMENS
• Common Device Name: APTIO BY SIEMENS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7667635
• Report Number: 2517506-2018-00413
• Device Sequence Number: 1554049
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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: APTIO BY SIEMENS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1