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

Catalog Number	K1061 SMN10445144
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) for the discordant phosphorus (phos) results obtained on the dimension vista instrument.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant phosphorus (phos) results.Headquarters support center (hsc) has reviewed the information provided as well as a review of instrument data.Based on review of calibration history, the customer calibrated phos using reagent lot 17291ac and used this calibration until (b)(6) 2018 when qc recovery was out of range high.The qc was run using flex sequence 104, well set 6;10;2.The issue was resolved by recalibrating phos using a new flex sequence 103 and well set 5;9;1.The discrepant patients were repeated and corrected reports were issued.After recalibration, the instrument is currently working as specified.No further action will be taken by hsc.No further evaluation of the device is required.
Event or Problem Description
Discordant depressed phosphorus (phos) results were obtained on multiple patient samples on the dimension vista 1500 instrument.The initial results were reported.One patient received treatment based on the discrepant result.The same patient samples were repeated after recalibration of the same flex reagent cartridge with an alternate flex well set higher results were obtained.Corrected reports were issued.There are no reports of patient intervention or adverse health consequences due to the discordant depressed phos results or due to patient treatment.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® PHOSPHORUS FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7297195
• Report Number: 2517506-2018-00102
• Device Sequence Number: 11098329
• Product Code: CEO
• UDI-Device Identifier: 00842768015700
• UDI-Public: 0842768015700
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/26/2018

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: 10/18/2018
• Device Catalogue Number: K1061 SMN10445144
• Device Lot Number: 17291AC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1