MAUDE Adverse Event Report: 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 06/15/2018

Event Type  malfunction  

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 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
• Type of Device: APTIO BY SIEMENS
• Manufacturer (Section D): 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: 7667635
• MDR Text Key: 113638044
• Report Number: 2517506-2018-00413
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: APTIO BY SIEMENS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/06/2018
• 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