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 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The ccc specialist determined that quality controls (qc) recovery was within acceptable ranges.The specialist performed troubleshooting and determined the sample probe 1 failed the bottom of the cuvette correction (bocc) when running the alignment.The ccc specialist did not identify issues during review of probe counts, and decided to clean all probes and drains, and replaced the sample probe.The alignment of the sample probe 1, and reagent arm 1 and reagent arm 2 probes were performed.A check 1 was performed on the sample probe and testing passed.The specialist performed the bocc and then service method testing (smt) was performed and passed.A precision of glucose was performed to evaluate the performance of the instrument and it was determined that all results were within specifications.A siemens headquarter support center (hsc) specialist evaluated the troubleshooting performed by the ccc and determined the issue is related to the sample probe 1 and bottom of the cuvette correction (bocc) alignment failure.The hsc specialist informs that the customer has continued to run patient samples and the instrument is performing within specifications.No further evaluation of device is required.

Event Description

A discordant, falsely depressed glucose (glu) result was obtained on a dimension vista 500 instrument.The discordant result was not reported to the physician(s).The instrument was configured to auto-repeat panic results for glu and the repeated result was higher and considered a glu result that is normal.The customer performed repeat testing on an alternate dimension vista instrument and the result of 81 mg/dl was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely depressed glu result.

• 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; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7385230
• MDR Text Key: 104040912
• Report Number: 2517506-2018-00216
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: 00630414949581
• 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
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• 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: 03/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2009
• 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