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 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The customer had obtained lipemia index of 5 for sample id (b)(6).A siemens headquarters support center (hsc) specialist reviewed the instrument data and determined that the sample preceding sample id (b)(6) generated multiple errors including integrated multi-sensor technology (imt) error and e-verify and above assay range flags.The data suggested poor sample quality and presence of gel, microclots, fibrin, and/or cellular material for the sample that generated the multiple errors.Sample id (b)(6) (preceding sample), impacted the imt probe and imt dilution for sample id (b)(6) and the subsequent sample id (b)(6), i.E.The sample in question.The sample following sample id (b)(6) generated results within the normal reference range and without above reference range flags.A high concentration of solids (lipemia) in the sample is expected to result in low, not high electrolyte recovery due to displacement of the aqueous portion of the sample with the lipids.The dimension vista v-lyte® integrated multisensor instructions for use shows < 10% interference with lipemia up to a triglyceride concentration of 3000 mg/dl.The 'l' flag for lipemia at an index of 5 is equivalent to approximately 400-600 mg/dl.Therefore, the lipemia interference of sample id (b)(6) has been ruled out as a contributing factor for the discordant result obtained for the initial run of sample id (b)(6).No change to any imt fluids occurred during this time frame ruling out an improper dilution due to the insufficient fluids.The hsc specialist concluded that the cause of the issue was due to an improper imt dilution for an error condition generated from the sample prior to sample id (b)(6), which impacted the subsequent imt dilution for sample id (b)(6).The instrument is performing within manufacturing specifications.No further evaluation if device is required.

Event Description

A discordant, falsely elevated sodium (na) 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 after ultracentrifugation and the result was lower.The sample was then repeated on an alternate dimension vista instrument, also resulting lower.There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated na result.

• 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 ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6707053
• MDR Text Key: 80047430
• Report Number: 2517506-2017-00584
• Device Sequence Number: 0
• Product Code: JGS
• 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
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• 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: 06/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2010
• 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: 77 YR