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

Catalog Number K1061 SMN10445144

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2018

Event Type  malfunction  

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 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®
• Type of Device: DIMENSION VISTA® PHOSPHORUS 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: 7297195
• MDR Text Key: 101155264
• Report Number: 2517506-2018-00102
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 00842768015700
• UDI-Public: 0842768015700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2018
• Device Catalogue Number: K1061 SMN10445144
• Device Lot Number: 17291AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2017
• 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