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

Catalog Number K3057, SMN 10445158

Device Problem Low Test Results (2458)

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center.The customer used a different mg reagent cartridge of the same reagent lot as part of routine troubleshooting.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A discordant low magnesium (mg) result was obtained on a patient sample on the dimension vista 500 system.The low result was reported to the physician and not questioned.The patient received magnesium sulfate.The same sample was repeated on an alternate dimension vista system and a higher result was obtained.There was no report of adverse health consequences as a result of the discordant low mg result and subsequent magnesium sulfate treatment.

Manufacturer Narrative

Original mdr 2517506-2016-00372 was filed (b)(6) 2016.Siemens headquarters support center (hsc) has completed an investigation of the incident.The sample id is (b)(4).Hsc review of the data indicates that an abnormal assay flag was observed for the initial run of sample id (b)(4).The reagent 2 blank (cuvette 2) was low.Hsc was unable to further identify and determine the root cause of this error condition with a falsely low mg result.Reagent 2 blanks returned to expected values without error with a new wellset from the same flex.However, the definitive root cause for why the reagent blank was low or insufficient reagent was contained in the flex cannot be determined based on the data available.No further hsc investigation is possible.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® MG MAGNESIUM FLEX REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: edward szymanski ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026317672
• MDR Report Key: 6075438
• MDR Text Key: 59040555
• Report Number: 2517506-2016-00372
• Device Sequence Number: 1
• Product Code: JGJ
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

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: 07/07/2017
• Device Catalogue Number: K3057, SMN 10445158
• Device Lot Number: 16189BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1