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

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer's quality control (qc) was within the acceptable range on the day the event occurred.The repeat testing was run with a new reagent well set after the customer had bumped the old one.A siemens customer service engineer (cse) was dispatched to the customer site.The cse inspected the wells and verified the stamp on the questionable flex.The cse performed verification on the wells by running patient comparison with other dimension vista instruments, resulting within range.The cse ran qc, resulting within range.The reagent lot in question was sent to the technical support laboratory for assessment.Calibration and qc testing met acceptable limits.A patient plasma sample was run in "batch mode", for a total of 600 tests, and no outliers were obtained.The issue could not be confirmed.The cause of the discordant, falsely low ca result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed calcium (ca) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ca result.

Manufacturer Narrative

Original mdr 2517506-2017-00790 was filed (b)(6) 2017.The siemens healthcare diagnostics technical solutions laboratory (tsl) and headquarters support center (hsc) conducted further investigation on lot 17171bd calcium (ca) flex reagent cartridges returned from the customer.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 greater than 0.6 mg/dl (0.15 mmol/l) within an individual well set.The issue does not occur in every flex sequence and not every well set.Siemens is continuing to investigate the reagent issue.

Manufacturer Narrative

Original mdr 2517506-2017-00790 was filed 10/26/2017.Mdr 2517506-2017-00790 supplement 1 was filed 11/30/2017.Mdr 2517506-2018-00089 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: 6981518
• MDR Text Key: 90959422
• Report Number: 2517506-2017-00790
• Device Sequence Number: 1
• Product Code: CIC
• Combination Product (y/n): N
• PMA/PMN Number: K051087
• 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,Followup
• Report Date: 02/09/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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 Model Number: DIMENSION VISTA 1500
• 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