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

Catalog Number	K1023 SMN 10445160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Discordant falsely depressed calcium (ca) results were obtained on patient samples on the dimension vista 1500 instrument s/n (b)(4).The results were not reported to the physician(s).The same samples were repeated on alternate dimension vista instruments and higher results were obtained and reported.There is no known report of patient intervention or adverse health consequences due to the discordant falsely depressed ca results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: 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: 7255126
• Report Number: 2517506-2018-00043
• Device Sequence Number: 16447504
• Product Code: CIC
• UDI-Device Identifier: 00842768015618
• UDI-Public: 00842768015618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-02/01/2018-001-R
• Patient Sequence Number: 1