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

Catalog Number K1167 SMN10445146

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

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 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®
• Type of Device: 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
• 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: 8185331
• MDR Text Key: 131920177
• Report Number: 2517506-2018-00678
• 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: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Catalogue Number: K1167 SMN10445146
• Device Lot Number: 18233BH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1