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

Catalog Number K1023 SMN 10445160

Device Problem Low Test Results (2458)

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

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) stating that they had gotten a complaint from a physician in regards to a low calcium (ca) result.The result was low relative to the result obtained with an alternate non-siemens instrument system.The customer noted that quality control (qc) results for the date the sample was run were within acceptable ranges and no proficiency testing failures have occurred.Siemens is investigating the incident.

Event Description

A discordant falsely depressed calcium (ca) result was obtained on a patient sample on the dimension vista 500 instrument.The result was reported to the physician who questioned the result.The same sample was repeated on an alternate non-siemens instrument system and a higher result was obtained.No corrected report was issued.There is no known report of patient intervention or adverse health consequences due to the discordant falsely depressed ca result.

Manufacturer Narrative

The original mdr 2517506-2018-00078 was filed 06-feb-2018.Additional information (07-feb-2018): siemens headquarters support center (hsc) has completed the investigation of the incident.Hsc confirmed that the siemens methodology is a different methodology than the methodology used at the alternate facility where higher calcium results were obtained.Due to methodology differences, calcium recovery can vary across different manufacturer's assays and instrumentation.Based on the information provided, there is no evidence of a product nonconformance.The customer stated that there have been no cap proficiency survey failures.The assay is performing as expected and consistent with peer.No further evaluation is required.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® CA CALCIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7244055
• MDR Text Key: 99788291
• Report Number: 2517506-2018-00078
• Device Sequence Number: 1
• Product Code: CIC
• UDI-Device Identifier: 00842768015618
• UDI-Public: 00842768015618
• Combination Product (y/n): N
• PMA/PMN Number: K061792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2018
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 17206BC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1