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 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The quality controls (qc) were within range on the day of the event.Siemens is investigating the issue.

Event Description

A discordant, falsely depressed urine creatinine (crea) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was not reported to the physician(s).The sample was repeated on an alternate dimension vista instrument, resulting higher.The customer poured a new aliquot of the same sample, respun and tested on the same dimension vista instrument and on alternate dimension vista instrument, both resulting higher and similar to the repeat result from the original aliquot.The corrected result from the alternate dimension vista instrument was reported to the physician(s).There are no reports of adverse health consequences due to the discordant, falsely depressed crea result.

Manufacturer Narrative

The initial mdr 2517506-2017-00152 was filed on (b)(6) 2017.Additional information (03/21/2017): a siemens headquarters support center (hsc) specialist reviewed the instrument data.The instrument data showed process errors on aliquot probe sample aspiration, insufficient sample in tube and clog detect errors on day of the event occurrence.There was no indication of reagent delivery issue based on the result monitor.The hsc specialist recommended the customer to spin samples prior to testing.The customer stated that they spin all urine samples prior to testing them.There are no reports of additional discordant results.The cause of the discordant, falsely depressed urine creatinine result on one patient sample is unknown.The instrument is performing within manufacturing specification.No further evaluation of device is required.

• 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 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6321827
• MDR Text Key: 67342956
• Report Number: 2517506-2017-00152
• Device Sequence Number: 0
• Product Code: CGX
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2012
• 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