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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER Back to Search Results
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.
 
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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 Key6459021
MDR Text Key71712653
Report Number2517506-2017-00343
Device Sequence Number0
Product Code MQM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051087
Number of Events Reported1
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 NumberDIMENSION 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 Received04/04/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/24/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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