MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 1500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The quality controls (qc) were within range on the day of the event.A siemens headquarter support center (hsc) reviewed the data related to this event.Original samples from both patients were discarded after the initial run.The customer did not perform repeat testing on the samples in question and therefore, it is unknown if the elevated tsh values obtained during the initial run were repeatable.The hsc concluded that retesting of the original samples is needed to determine if the cause of the event is due to sample integrity, instrument performance or patient physiology.The cause of the elevated tsh results on two patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Elevated thyroid stimulating hormone (tsh) results were obtained on two patient samples on a dimension vista 1500 instrument (serial number (b)(4)).The elevated results were reported to the physician(s).The patients were given levothyroxine treatment for elevated tsh results.Both patients were redrawn and tested on an alternate dimension vista instrument (serial number (b)(4)), resulting lower.The redraw results were reported to the physician(s), who questioned the results going from high to low.There are no reports of adverse health consequences due to the elevated tsh results.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6200109
• MDR Text Key: 63202561
• Report Number: 2517506-2016-00541
• Device Sequence Number: 0
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1