MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® VISTA CARDIAC TROPONIN I CALIBRATOR; CTNI CAL

Catalog Number KC678

Device Problems High Test Results (2457); Calibration Problem (2890)

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

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that cause for the discordant elevated troponin i qc results occurred following calibration.According to the customer, the calibrator may not have been handled correctly.Replacement calibrator was shipped to the customer for troubleshooting purposes and the system was recalibrated.Qc results were within range following re-calibration.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Dimension vista cardiac troponin i (ctni) qc values shifted high following calibration.Level 1 and level 2 qc was out.Patient samples were processed and reported.Physicians did not question the results.It is unknown if patient treatment was altered or prescribed as a result of reporting ctni results with qc out.There was no report of adverse health consequences as a result of reporting ctni results with qc out.

• Brand Name: DIMENSION® VISTA CARDIAC TROPONIN I CALIBRATOR
• Type of Device: CTNI CAL
• 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: 5102885
• MDR Text Key: 26854357
• Report Number: 2517506-2015-00178
• Device Sequence Number: 0
• Product Code: MMI
• Reporter Country Code: US
• PMA/PMN Number: K053577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/01/2016
• Device Catalogue Number: KC678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1