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 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens healthcare diagnostics customer care center about the discordant falsely depressed ca result.The siemens healthcare diagnostics headquarters support center (hsc) conducted an investigation on lot 17171bd calcium (ca) flex reagent cartridges.Headquarters support center (hsc) has confirmed that when using the dimension vista calcium (ca) reagent lot 17171bd, quality control (qc) and patient samples may show decreased recovery of >0.6 mg/dl (0.15 mmol/l) within an individual well set.Siemens is continuing to investigate the device issue.

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 dimension vista instrument and a higher result was obtained.A 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

Original mdr 2517506-2017-00837 was filed 12/14/2017.Mdr 2517506-2018-00092 was filed for the same incident.Siemens healthcare diagnostics has confirmed that dimension vista® calcium (ca) flex® reagent cartridge lot 17171bd may produce erroneously low results from specific well sets.If ca reagent calibration is performed using an unaffected well set and qc and patient samples are subsequently processed using an affected well set, ca results may be falsely depressed up to -2.8 mg/dl (-0.7 mmol/l).If ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated.The observed bias for serum, plasma, and urine specimens are similar.Urgent medical device recall, vc-18-03.A.Us and urgent field safety notice vc-18-03.A.Ous dated january 2018 were issued to customers who had been shipped dimension vista® calcium (ca) flex® reagent lot 17171bd.Customers were instructed to discontinue use and to discard lot 17171bd.

• 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: 7116727
• MDR Text Key: 96002848
• Report Number: 2517506-2017-00837
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 17171BD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2517506-02/01/2018-001-R
• Patient Sequence Number: 1