MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER,

Model Number DIMENSION VISTA 500

Device Problem Device Issue (2379)

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

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Quality controls were within range for free triiodothyronine (ft3) and free thyroxine on the day the event occurred.A siemens headquarter support center (hsc) specialist investigated the incident and has concluded that the product performed as designed and no product issue was found.The investigation results are consistent with patient specific non-specific binding interference causing the elevated ft3 and ft4 values.Patient samples that produce ft3 and ft4 values that are elevated, patient specific, discordant with the medical impression, with an alternate method values which were normal, is consistent with non-specific binding interference.All immunoassay methods are susceptible to none specific binding interference due to a variety of heterophilic antibodies or other globulins.The dimension vista system like other immunochemistry systems uses blocking antibodies and other reagents to minimize cross reactivity with non-specific antibodies.The cause of the discordant, falsely elevated ft3 and ft4 results is an isolated incident with the patient sample cross reactivity with non-specific antibodies not recognized by the blocking agent.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated free triiodothyronine (ft3) and free thyroxine (ft4) results were obtained on one patient sample on a dimension vista 500 instrument.The discordant results were reported to the physician(s), who questioned them.The sample was repeated at another laboratory on an advia centaur instrument, resulting lower.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ft3 and ft4 results.

• Brand Name: DIMENSION VISTA 500
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6048134
• MDR Text Key: 58132709
• Report Number: 2517506-2016-00366
• Device Sequence Number: 0
• Product Code: CEC
• 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: Other
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2010
• 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