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

Model Number	K5020
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and questioned an elevated salicylate (sal) patient result that was obtained on the dimension vista system.Siemens is investigating the event.
Event or Problem Description
A discordant elevated salicylate (sal) result was obtained on a patient serum sample on the dimension vista 500 system.The result was reported to the physician(s).The same sample was processed on the customer's alternate dimension vista system and an elevated result was obtained.The same sample was processed on an alternate non-siemens system and a lower result was obtained.The patient was administered a medication for salicylate poisoning.There are no known reports of adverse health consequences due to the discordant elevated salicylate result or the medication treatment.
Additional Manufacturer Narrative
Initial mdr was filed 29-jun-2020.Additional information (29-jun-2020): siemens headquarters support center (hsc) completed the investigation of the falsely elevated salicylate (sal) event.Hsc has reviewed the information provided and the instrument data logs and has observed no product non-conformance.The customer processed two separate tubes from the same sample draw and reported consistent results on two separate dimension vistas located at the customer site.All patient samples displayed icterus interference flags.As per the dimension vista's operators guide, the icterus error reports that the estimated amount of bilirubin in the sample is interfering with the test results.Bilirubin concentrations and potential bias is indicated within the sal assay instructions for use.The cause of the event was specific to the patient samples.All samples associated with the event displayed elevated icterus interference flags which may bias the reported salicylate results.The customer is operational.No additional discordant results or assay concerns were reported by the customer.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® SAL SALICYLATE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10206870
• Report Number: 2517506-2020-00193
• Device Sequence Number: 2107542
• Product Code: DKJ
• UDI-Device Identifier: 00842768015427
• UDI-Public: 00842768015427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 09/15/2020
• Device Model Number: K5020
• Device Catalogue Number: SMN 10445108
• Device Lot Number: 19259BD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1