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

Model Number DIMENSION VISTA 500

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

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

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The customer stated that quality control (qc) results were within specification before and after the samples were processed and the data does not indicate any errors with the instrument.The cause of the false positive bhcg result is unknown.Siemens is investigating the issue.

Event Description

A discordant, false positive beta human chorionic gonadotropin (bhcg) result was obtained on an emergency room (er) patient serum sample on a dimension vista 500 instrument.The result was reported out.The positive result was given to the patient, who did not believe the result was possible.The sample was repeated on the same instrument, resulting negative.The sample was then repeated on the same instrument using a plasma sample, also resulting negative.The corrected negative result was reported to the physician(s).There no known reports of patient intervention or adverse health consequences due to the discordant, false positive bhcg result.

Manufacturer Narrative

The initial mdr 2517506-2017-00525 was filed on june 19, 2017.Additional information (07/21/2017): a siemens headquarters support center (hsc) specialist reviewed the instrument data which indicated that the customer is not centrifuging specimens per the tube manufacturer's instruction for use (ifu).Hsc concluded that these issues are sample specific, consistent with specimen integrity issue.The cause of the discordant, false positive beta human chorionic gonadotropin (bhcg) result is associated with sample integrity issue.The instrument is performing within manufacturing specifications.No further evaluation of device is required.Updated conclusion code.

• 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: 6650658
• MDR Text Key: 77879951
• Report Number: 2517506-2017-00525
• Device Sequence Number: 0
• Product Code: DHA
• 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,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2013
• 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