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

Catalog Number	K1167 SMN10445146
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed total bilirubin result.The tbil ifu indicates that any "report containing flags and/or comments should be addressed according to your laboratory's procedure and not reported": limitations of procedure: the instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in total bilirubin results.Refer to your dimension vista® operator's guide for the meaning of report flags and comments.Any report containing flags and/or comments should be addressed according to your laboratory's procedure manual and not reported.The data indicates the system is flagging correctly for a hemolysis error and is working as specified.Hsc has reviewed the information provided and concludes that it is not a reagent lot or method issue.There is no evidence of a product nonconformance.The system is working as specified and flagging correctly for the presence of hemolysis for tbil samples.Hsc concludes the cause of this event of reporting of falsely low tbil results for sample id (b)(6) was due to operator error.The operator reported tbil results with e111: hemolysis error.Results with a hemoglobin error are not reportable.No product non-conformance was identified with the instrument or reagent.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely depressed total bilirubin result with a e111 hemolysis error flag was obtained on a neonate patient sample on the dimension vista instrument.The discordant result was reported to the physician(s) who questioned the result.A new sample drawn from the same patient was processed the next day on the original instrument and a higher result was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed total bilirubin (tbil) result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® TOTAL BILIRUBIN (TBIL) FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8185331
• Report Number: 2517506-2018-00678
• Device Sequence Number: 19194269
• Product Code: CIG
• UDI-Device Identifier: 00842768015717
• UDI-Public: 00842768015717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/20/2018

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: 08/21/2019
• Device Catalogue Number: K1167 SMN10445146
• Device Lot Number: 18233BH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1