MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION EXL(R) SYSTEM

Model Number DIMENSION VISTA 1500

Device Problems False Device Output (1226); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

A falsely depressed troponin i (tni) result was obtained on a patient sample on a third sequential sample.The patient result was reported to the physician who questioned the result.Prior sequential samples had been positive.The laboratory later repeated the test on an alternate dimension vista instrument and a higher result was obtained and reported.Patient treatment was not altered or prescribed on the basis the falsely depressed troponin i (tni) result.There was no report of adverse health consequences as a result of the falsely depressed troponin i (tni) result.

Manufacturer Narrative

Analysis of the instrument and instrument data by the customer indicated that the cause of the falsely elevated troponin i (tni) result was unknown.The instrument data did not indicate an issue with the reagent or instrument performance.Sample integrity could not be assessed.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION EXL(R) SYSTEM
• Type of Device: DIMENSION EXL(R) SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3892098
• MDR Text Key: 21495226
• Report Number: 1226181-2014-00343
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1