MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® MAGNESIUM (MG) FLEX® REAGENT CARTRIDGE

Model Number 10445158

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2022

Event Type  malfunction  

Event Description

Fifteen (15) discordant, falsely depressed magnesium (mg) patient sample results were obtained on a dimension vista 1500 system.The results were reported to the physician.The same samples were reprocessed on an alternative dimension vista system and higher results, considered correct, were obtained.Corrected reports were issued.There were unconfirmed reports that multiple patients were treated based on the discordant results.There were no known reports of adverse health consequences to the patients due to the discordant magnesium results or treatment.

Manufacturer Narrative

A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant falsely depressed patient sample results on a dimension vista system.There were no known reports of adverse health consequences or potential for serious injury to the patients due to the discordant magnesium results or treatment administered.This mdr is being filed conservatively as the patients may have received treatment.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the falsely depressed patient sample magnesium results on a dimension vista system.Siemens healthineers has confirmed that the dimension vista magnesium (mg) flex reagent cartridge lots 21253bb, 21263ba and 21335aa may show higher imprecision across the analytical measurement range for quality control and patient samples.Customers have reported a maximum negative difference of (b)(6) mg/dl (-0.9 mmol/l) between two replicates and maximum positive difference between two replicates to be 1.5 mg/dl (0.6 mmol/l).Urgent medical device correction vc-22-01.A.Us was issued to united states customers and urgent field safety notice (ufsn) vc 22-01.A.Ous was sent to outside the us (ous) customers advising customer to discontinue use and discard these dimension vista magnesium lots.

Manufacturer Narrative

Additional information (18-feb-2022).Siemens healthcare diagnostics, inc.Filed corrections and removal report (crr) dated (b)(6) 2022 with the fda per 21 cfr 806.10.Root cause investigation is in progress and corrective action updates will be provided in monthly status update reports to the fda as per 21 cfr part 806.10.Initial mdr 2517506-2022-00035 was filed 18-feb-2022.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® MAGNESIUM (MG) FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 13558842
• MDR Text Key: 287824821
• Report Number: 2517506-2022-00035
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00842768015694
• UDI-Public: 00842768015694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 10445158
• Device Catalogue Number: K3057 SMN 10445158
• Device Lot Number: 21335AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-02/08/2022-001-C
• Patient Sequence Number: 1