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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA1500
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SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA1500 Back to Search Results
Model Number DIMENSION VISTA1500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2017
Event Type  malfunction  
Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report the discordant glucose result.A siemens headquarter support center (hsc) has reviewed the information provided and does not suspect reagent or instrument issues since no other samples were affected.The assay is performing within specifications.All quality control (qc) was within range the day of testing and consistent with peer recovery.The sample was repeated and verified with a redraw of the patient.The repeat from the original sample and the results from the redraw were identical.There was no indication of an instrument malfunction.Hsc concludes that the likely cause of the issue is related to sample handling or to sample integrity.The cause of the discordant falsely low glucose result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.
 
Event Description
A discordant, falsely high glucose result was obtained on one patient sample on a dimension vista 1500 instrument.The discordant result was reported to the physician(s), who questioned it.The customer tested a newly drawn sample on the original instrument, and recovered lower.The new sample was repeated two more times on the alternate instrument, and the result matched to the rerun result.The result obtained with the new draw was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant glucose result.
 
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Brand Name
DIMENSION VISTA1500
Type of Device
DIMENSION VISTA1500
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
margarita karan
511 benedict avenue
tarrytown, NY 10591
9145243105
MDR Report Key6692934
MDR Text Key79267958
Report Number2517506-2017-00577
Device Sequence Number0
Product Code CFR
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 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDIMENSION VISTA1500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2010
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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