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

Catalog Number K1023 SMN 10445160

Device Problem Low Test Results (2458)

Patient Problem Missing Value Reason (3192)

Event Date 10/07/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens healthcare diagnostics customer care center about the discordant falsely depressed ca results.The cause of the discordant falsely depressed ca results is unknown.The incident is under investigation by the siemens headquarters support center (hsc).

Event Description

Discordant falsely depressed calcium (ca) results were obtained on patient samples on the dimension vista 1500 instrument.The results were reported to the physician(s) who did not question the results.The same samples were repeated on the same instrument with an alternate ca flex reagent cartridge.Higher results were obtained.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed ca results.

Manufacturer Narrative

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 >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 2517506-2017-00765 was filed 11/01/2017.Mdr 2517506-2017-00765 supplement 1 was filed 11/30/2017.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 - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6992761
• MDR Text Key: 91333719
• Report Number: 2517506-2017-00765
• Device Sequence Number: 1
• Product Code: CIC
• UDI-Device Identifier: 00842768015618
• UDI-Public: 00842768015618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-02/01/2018-001-R
• Patient Sequence Number: 1