MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE

Model Number	10700444
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding three (3) discordant falsely depressed enzymatic creatinine (ecrea) patient sample results obtained on a dimension vista 1500 system.Siemens is investigating the event.
Event or Problem Description
Three (3) discordant falsely depressed enzymatic creatinine (ecrea) patient sample results were obtained on a dimension vista 1500 system.The discordant results were not reported to the physician(s).The same samples were reprocessed on the same system and higher ecrea results, considered correct, were obtained.Additionally, the higher reprocessed results were verified with an alternate dimension vista system.The reprocessed ecrea results from the initial dimension vista system were reported as the correct results.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed enzymatic creatinine (ecrea) results.
Additional Manufacturer Narrative
Additional information (29-apr-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data logs.The dimension vista 1500 system and enzymatic creatinine (ecrea) assay were performing acceptably.Quality control results were within the customer's expected ranges.Repeat of the same samples yielded expected results.A potential product issue was not identified.The cause of the event is unknown.System is fully functional.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2022-00080 was filed on 20-apr-2022.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 14159584
• Report Number: 2517506-2022-00080
• Device Sequence Number: 11498998
• Product Code: JFY
• UDI-Device Identifier: 00842768036262
• UDI-Public: 00842768036262
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K090330
• 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,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 09/14/2022
• Device Model Number: 10700444
• Device Catalogue Number: K1270A SMN 10700444
• Device Lot Number: 21287AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2021
• 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