MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® MG MAGNESIUM FLEX® REAGENT CARTRIDGE

Catalog Number	K3057 SMN10445158
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported that discordant, abnormal assay error flagged, falsely depressed magnesium (mg) patient results were obtained on the dimension vista 1500 system.Headquarters support center (hsc) has reviewed the information provided and concluded that it is not a mg reagent lot or method issue.There is no evidence of a product nonconformance.The customer has been using mg reagent lot 18032bb without issue and was using the same mg reagent lot on an alternate vista without any issue.All quality control (qc) was within customer ranges.The customer reported the two patient samples in error.The mg results were appropriately flagged by the vista instrument.Based on the information provided, hsc is unable to determine the cause of this event.The customer replaced the mg flex in use with a different mg flex from the same mg reagent lot 18032bb and has experienced no issue.This event represents use error due to the reporting of error flagged results which are non-reportable values.The patient results were flagged appropriately by the instrument.Vista operators guide states: abnormal assay [e143]: outside computed results monitoring limits explanation: the result monitor feature uses existing loci, nephelometric, and photometric reads to check for reagent quality and delivery and, for some methods, sample delivery.The message indicates that expected absorbance/kcounts were not met for a specific cuvette or loci reaction vessel.What to do: the result cannot be reported.Rerun the sample.The instrument is performing according to specifications.No further evaluation of the instrument is required.
Event or Problem Description
Discordant, abnormal assay error flagged, falsely depressed magnesium (mg) results were obtained on two patient samples on the dimension vista 1500 system.The results were reported to the physician.The physician requested new samples from the patients.The new samples were processed and higher results were obtained.The original samples were processed again at a later date and higher results were obtained.Corrected reports were issued.The customer stated that both patients received treatment however, there was no indication of the type of treatment received.(complaint states: floor nurse indicated the patient was treated for the low mg but did not * elaborate on the treatment.) there are no known reports of adverse health consequences due to the discordant, abnormal assay error flagged, falsely depressed magnesium (mg) results or treatment.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® MG MAGNESIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7526057
• Report Number: 2517506-2018-00319
• Device Sequence Number: 13809262
• Product Code: JGJ
• UDI-Device Identifier: 00842768015694
• UDI-Public: 00842768015694
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140790
• 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): 05/18/2018

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: 02/01/2019
• Device Catalogue Number: K3057 SMN10445158
• Device Lot Number: 18032BB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1