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 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that they cleaned the drains and probes of aliquot reagent 1 probe, reagent 2 probe and sample 1 probe.The customer repeated the sample in question and the result was acceptable.The customer did not obtain additional discordant results.The cause of the discordant, falsely low bhcg result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

A discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on one patient sample on a dimension vista 1500 instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument and on an alternate dimension vista instrument, resulting higher both times.The result obtained on the alternate dimension vista instrument was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low bhcg result.

Manufacturer Narrative

The initial mdr 2517506-2017-00495 was filed on may 18, 2017.Additional information (07/19/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and determined that prior to and after the discordant result was obtained, quality control was run from the same well set and was within acceptable range.Sample for the repeat run was reintroduced on the system with a small sample container cup and was repeated on an alternate dimension vista instrument, which matched the expected result.There was no indication that the system was malfunctioning or having an issue with the beta human chorionic gonadotropin (bhcg) assay around this time.There was no mention of sample handling or pre-analytical factors.The hsc specialist stated the initial sample from the primary tube could potentially introduced fibrin or cellular debris, which may have caused the lower result.The hsc specialist recommended the customer to follow proper pre-analytical sample handling procedures and tube manufacturer's instructions, including mixing of the sample after phlebotomy to ensure complete dispersion of the anti-coagulant or clot activator throughout the sample in order to avoid latent fibrin formation in the serum or plasma portion of the sample.The cause of the discordant, falsely low bhcg result on one patient sample is unknown.

• 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 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6575542
• MDR Text Key: 75522505
• Report Number: 2517506-2017-00495
• 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
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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: 07/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2011
• 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: 28 YR