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 Consequences Or Impact To Patient (2199)
Date of Event	05/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported a discordant, falsely depressed enzymatic creatinine (ecrea) result was obtained on a dimension vista 500 system.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely depressed enzymatic creatinine (ecrea) result was obtained on a patient plasma sample on a dimension vista 500 system.The result was reported to the physician(s).The same sample was reprocessed on the same instrument and a higher result was obtained, considered correct and reported.A corrected report was issued.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ecrea result.
Additional Manufacturer Narrative
Mdr 2517506-2020-00175 was filed on 11-jun-2020.Additional information (15-jun-2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely depressed enzymatic creatinine (ecrea) result.Hsc evaluated the information provided and the instrument data files.Quality control was in range upon testing from subsequent new assay wells and no issues were noted with other patient samples, indicating that the instrument and assay were performing acceptably.Repeat of the same sample yielded expected results.A potential product issue has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• 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
• MDR Report Key: 10143416
• Report Number: 2517506-2020-00175
• Device Sequence Number: 3045137
• Product Code: JFY
• UDI-Device Identifier: 00842768036262
• UDI-Public: 00842768036262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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 Expiration Date: 11/01/2020
• Device Model Number: 10700444
• Device Catalogue Number: K1270A SMN 10700444
• Device Lot Number: 19336AA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1