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

Model Number 10700444

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2020

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 195482538
• Report Number: 2517506-2020-00175
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 00842768036262
• UDI-Public: 00842768036262
• Combination Product (y/n): N
• PMA/PMN Number: K090330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1