MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYVA® EMIT 2000; VALPROIC ACID

Model Number	VALPROIC ACID
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated valproic acid patient sample result was obtained on viva e system.The discordant patient result was reported to the physician and questioned.The same patient sample was reprocessed on the original system, and a lower valproic acid result was obtained.The lower reprocessed result was considered correct and reported.There were no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated patient result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center regarding a falsely elevated valproic acid patient sample result obtained on a viva e analyzer.Valproic acid quality control was within the customer acceptance range at the time the sample was run.A customer service engineer (cse) was dispatched to the site and found the temperature of the reagent compartment was high and replaced the refrigeration unit which returned the system to normal operation.The part replaced by the cse is part of normal troubleshooting/maintenance for issues of this nature.The cause of the event is unknown.The instrument is fully operational.The device is performing according to specifications.No further investigation is required.

• Brand Name: SYVA® EMIT 2000
• Common Device Name: VALPROIC ACID
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6104
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6104
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 13054771
• Report Number: 2517506-2021-00348
• Device Sequence Number: 17115753
• Product Code: LEG
• UDI-Device Identifier: 00842768000942
• UDI-Public: 00842768000942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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 Expiration Date: 06/04/2022
• Device Model Number: VALPROIC ACID
• Device Catalogue Number: SMN 10445312
• Device Lot Number: N4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown