MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

Model Number	ADVIA 1800
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Information regarding a siemens customer service engineer's (cse) inspection and evaluation is currently pending.Siemens will continue to further investigate the issue for probable cause.
Event or Problem Description
Discordant lipase patient result was obtained on an advia 1800 instrument.After an initial sample was run, repeat samples were repeated on the same instrument twice, resulting in higher values.The sample was repeated again the next day, resulting in a lower, discordant value.The repeat results were considered correct and reported to the physician(s).It was alleged that a medical procedure or treatment, that may have been unnecessary, was performed; the patient was sent to the emergency room.There are no known reports of adverse health consequences due to the discordant results and emergency room stay.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00361 on 04-oct-2019.The customer contacted a siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site.Cse inspected the instrument and found that quality control (qc) was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.The sample was repeated and resulted in an expected yield.The cause of the discordant lipase patient result is unknown.Contributing factors such as sample integrity, sample specific interferent, preanalytical variables, the methodology of the testing at the emergency room (er), could impact lipase recovery that can vary across different methodologies and cannot be ruled out.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00361 on 04oct2019.Siemens filed a follow-up mdr 2432235-2019-00361_s1 on 31oct2019.Additional information (23jan2020): siemens headquarter support center investigation determined the customer service engineer (cse) found that the screen of the test order did not comply with siemens recommendations and the 'contamination settings' were updated.Additionally, the cse reordered the 'detergent settings' screen.Siemens concluded that the cause of the discordant results were the incorrect instrument settings that allowed carryover.After the settings update, the system was fully functional.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 1800
• Common Device Name: ADVIA 1800
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 9158175
• Report Number: 2432235-2019-00361
• Device Sequence Number: 19410181
• Product Code: JJE
• UDI-Device Identifier: 00630414482446
• UDI-Public: 00630414482446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2020

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: ADVIA 1800
• Device Catalogue Number: 10315183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/14/2019; 01/28/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/31/2019; 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR