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

Catalog Number	K5088 SMN 10445110
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) about the discordant falsely elevated actm result.The ccc instructed the customer that the cause of the discordant falsely elevated result was user error in reporting a diluted result after a below assay range flagged original result.Dilution of a flagged below assay range sample is not prescribed in the actm instructions for use (ifu).The issue was resolved by customer education.Additionally, the sample was flagged for icterus interference both initially and on dilution: the actm instructions for use states in the limitations of procedure section: 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 acetaminophen 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 device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant falsely elevated, acetaminophen (actm) result was obtained on a patient sample on the dimension vista 500 instrument.The result was reported to the physician.The result was questioned by the physician.The customer stated that the patient was treated based on the discordant falsely elevated result on their belief of an acetaminophen overdose.It is unknown what treatment was provided to the patient.There are no known reports of adverse health consequences due to the discordant result or treatment.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® ACTM ACETAMINOPHEN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7130825
• Report Number: 2517506-2017-00877
• Device Sequence Number: 977850
• Product Code: LDP
• UDI-Device Identifier: 00842768015014
• UDI-Public: 00842768015014
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K061655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 07/24/2018
• Device Catalogue Number: K5088 SMN 10445110
• Device Lot Number: 17205AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1