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

Catalog Number K1167 SMN 10445146

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2018

Event Type  malfunction  

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 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®
• Type of Device: 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
• 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 ; 3026318356
• MDR Report Key: 7806495
• MDR Text Key: 118111707
• Report Number: 2517506-2018-00456
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00842768015717
• UDI-Public: 00842768015717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2019
• Device Catalogue Number: K1167 SMN 10445146
• Device Lot Number: 18123BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1