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.

• Brand Name: DIMENSION VISTA MAGNESIUM FLEX REAGENT CARTRIDGE
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; newark DE 19714 6101
• MDR Report Key: 13548922
• MDR Text Key: 285831616
• Report Number: MW5107519
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White