MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

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 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant beta human chorionic gonadotropin (bhcg) result.Quality control (qc) was within range.Siemens is investigating the issue.

Event Description

A discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on (b)(6) 2017, on one patient sample on a dimension vista 500 instrument.The initial result was reported to the physician(s) on (b)(6) 2017, the physician contacted the customer and reported that the patient is three months pregnant.It is unknown if repeat testing was performed.It is unknown if a corrected result was reported to the physician(s).It is alleged that the discrepant result caused an abortion to be delayed or withheld.

Manufacturer Narrative

Corrected information (01-december-2017): the patient sample was not repeated.A new sample was not obtained from the patient for testing.

Event Description

The patient sample was not repeated.A new sample was not obtained from the patient for testing.

Manufacturer Narrative

The initial mdr 2517506-2017-00894 was filed on 20-dec-2017.Supplemental mdr 2517506-2017-00894_s1 was filed on 26-dec-2017.Supplemental mdr 2517506-2017-00894_s2 was filed on 01-jan-2018.Additional information (16-jan-2018): the siemens hsc (headquarter support center) has performed an investigation.The customer has provided limited information and stated no repeat testing was performed and the original sample is not available for additional testing.While the centrifugation of the sample tube (id: (b)(6)) appears to be sufficient, poor sample quality or pre-analytical sample handling issues can also affect patient sample testing and results.The cause of the event is unknown.

Manufacturer Narrative

The initial mdr 2517506-2017-00894 was filed on 20-dec-2017.Supplemental mdr 2517506-2017-00894_s1 was filed on 26-dec-2017.A discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on (b)(6) 2017, on one patient sample on a dimension vista 500 instrument.The initial result was reported to the physician(s) on (b)(6) 2017.The physician contacted the customer when the patient visited the physician on (b)(6) 2017 and reported that the patient is three months pregnant.

Event Description

A discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on (b)(6) 2017, on one patient sample on a dimension vista 500 instrument.The initial result was reported to the physician(s) on (b)(6) 2017.The physician contacted the customer when the patient visited the physician on (b)(6) 2017 and reported that the patient is three months pregnant.

• Brand Name: DIMENSION VISTA 500
• Type of Device: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7135166
• MDR Text Key: 95901567
• Report Number: 2517506-2017-00894
• Device Sequence Number: 0
• Product Code: DHA
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2010
• 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
• Patient Age: 35 YR