MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc was granted remote access.The ccc reviewed the data provided.The customer's quality control (qc) was in at the time of the event.The ccc did not find any process errors associated with the event.The customer performed patient comparisons on their alternate dimension vista instruments, resulting within the expected clinical range.The ccc performed qc, resulting within range.The ccc performed a full quickcheck, failing for probe leak.The customer reseated the tubing and the ccc performed the reagent prep probe and saw no obvious leaks.The ccc primed the prop probe 30 times and repeated the quickcheck, resulting within specifications.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse replaced the sample probe 2 mixer.The cse aligned the sample probe 2 probe.The cse performed an overmix test, resulting within specifications.The cse performed and quickcheck and qc, resulting within range.The cause of the discordant, falsely elevated total bilirubin results is due to a malfunction of the sample probe 2 mixer.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated total bilirubin results were obtained on patient samples on a dimension vista 1500 instrument.The initial results were reported out to the physician(s).The customer repeated the same samples on an alternate dimension vista instrument, resulting lower.The customer issued corrected reports to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.

• 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 number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6459021
• MDR Text Key: 71712653
• Report Number: 2517506-2017-00343
• Device Sequence Number: 0
• Product Code: MQM
• 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: 04/04/2017

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: 03/09/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2008
• 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