MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® 1500 SYSTEM

Model Number	DIMENSION VISTA® 1500 SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) concerning a falsely depressed lipase (lipl) result obtained on a patient sample on a dimension vista® 1500 intelligent lab system.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely depressed lipase (lipl) result.Hsc reviewed the information provided by the customer and the instrument data.Quality control (qc) was within acceptable ranges.Repeat testing using the same sample generated an accurate result indicating that the dimension vista® 1500 system and lipase (lipl) assay were performing acceptably.No further issues have been reported.A potential product issue has not been identified.The cause of the event is unknown.The system is fully operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant falsely depressed lipase (lipl) result was obtained on a patient sample on a dimension vista® 1500 intelligent lab system.The discordant result was reported to the physician(s).The same sample was reprocessed on an alternate dimension instrument.The reprocessed result was higher than the discordant result and agreed with the patient's clinical picture.The reprocessed result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant lipl result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® 1500 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 14831080
• Report Number: 2517506-2022-00156
• Device Sequence Number: 2367798
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 00630414949536
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

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: DIMENSION VISTA® 1500 SYSTEM
• Device Catalogue Number: SMN 10459469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2018
• 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