MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. DIMENSION VISTA MAGNESIUM FLEX REAGENT CARTRIDGE; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number K3057

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2022

Event Type  malfunction  

Event Description

Failure of reagent for dimension vista mg flex reagent cartridge resulting in 10 pts receiving incorrect results of low magnesium level.Ten (10) pts affected, no negative outcomes noted at this time.

Event Description

Failure of reagent for dimension vista mg flex reagent cartridge resulting in 10 pts receiving incorrect results of low magnesium level.Ten (10) pts affected, no negative outcomes noted at this time.

• Brand Name: DIMENSION VISTA MAGNESIUM FLEX REAGENT CARTRIDGE
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• MDR Report Key: 13548950
• MDR Text Key: 285828153
• Report Number: MW5107522
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Catalogue Number: K3057
• Device Lot Number: 21253BB/21263BA/21335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White