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

Catalog Number K1023 SMN 10445160

Device Problem Low Test Results (2458)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the biased low ca patient result is unknown.Siemens healthcare is investigating the complaint.The mdr will be updated with the results of the investigation.

Event Description

The customer stated calcium (ca) patient results were biased low on the dimension vista instrument.An individual patient result was reported and questioned by the physician.The patients sample was retested on an alternate siemens instrument system (advia) and a higher result was recovered.There is indication that patient treatment was altered on the basis of the low ca result on the vista.The physician did not administer the medication prolia (denosumab) due to the low ca result.There was no report of adverse health consequences as a result of discrepant low ca result or the decision not to administer the medication.

• Brand Name: DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE
• Type of Device: DIMENSION VISTA® CA 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: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5774822
• MDR Text Key: 48930853
• Report Number: 2517506-2016-00269
• Device Sequence Number: 1
• Product Code: CIC
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 07/07/2016

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: Medical Technologist
• Device Expiration Date: 12/02/2016
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 15337BC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1