MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 500

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data provided.The ccc found the customer's quality control (qc) was in range at the time of the event.The ccc reviewed the error log and found no issues.The ccc ran service method testing (smt), resulting out of range.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse replaced the valve on the sample pump panel and sample probe.The cse aligned the sample probe.The cse ran air elimination, twice.The cse emptied the tank, primed the system and repeated smt.Smt was out of specifications.The cse replaced the pump assembly for sample probe 1 and ran a quick check, resulting within range.The cse ran all service methods for sample probe 1, resulting within range.The cse performed qc, resulting within range.The cause of the discordant, falsely depressed magnesium results is due to a malfunction of the pump assembly.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed magnesium results were obtained on five patient samples on a dimension vista 500 instrument.The initial results were not reported out to the physician(s).The customer repeated the same sample on an alternate dimension vista instrument, resulting higher.The customer reported out the repeat results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed magnesium results.

• 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; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6437851
• MDR Text Key: 70983722
• Report Number: 2517506-2017-00304
• Device Sequence Number: 0
• Product Code: JGJ
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/27/2017

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 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2011
• 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