MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® TBIL TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE

Catalog Number	K1167 SMN 10445146
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00457 was also filed for the same event.The customer contacted the siemens customer care center (ccc) about a discordant depressed patient total bilirubin (tbil) result obtained on the dimension vista.Siemens headquarters support center (hsc) completed their evaluation of the event.Hsc examined the instrument data logs and confirmed that the hemoglobin concentration in the sample was well above the instructions for use (ifu) limit and was appropriately flagged.It correlates with the hemoglobin (h) recovery for the hil flag.Results with a hemoglobin error are not reportable.The tbil ifu limitations of procedure section states: "any report containing flags and/or comments should be addressed according to your laboratory's procedure manual and not reported." the device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant falsely depressed total bilirubin (tbil) result was obtained on a patient sample on the dimension vista 1500 system.The result was flagged for hemolysis (e111 flag) but was reported to the physician.A new sample drawn the same day was processed and a higher result was obtained consistent with the clinical picture and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed tbil result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® TBIL TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7806495
• Report Number: 2517506-2018-00456
• Device Sequence Number: 1469007
• Product Code: CIG
• UDI-Device Identifier: 00842768015717
• UDI-Public: 00842768015717
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061719
• 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
• Report Date (Section B): 08/22/2018

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: 05/03/2019
• Device Catalogue Number: K1167 SMN 10445146
• Device Lot Number: 18123BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1