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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGANOSTICS INC. DIMENSION XPAND PLUS WITH HM; CLINICAL CHEMISTRY ANALYZER
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SIEMENS HEALTHCARE DIAGANOSTICS INC. DIMENSION XPAND PLUS WITH HM; CLINICAL CHEMISTRY ANALYZER Back to Search Results
Model Number DIMENSION XPAND PLUS WITH HM
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2017
Event Type  malfunction  
Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).The customer stated that quality controls (qc) were in range at the time the event occurred.Ccc reviewed the instrument maintenance log and found no issue.The ccc specialist instructed the customer to replace the sampler and reagent probe 1 (r1) due to number of cycles and age.The ccc specialist inspected the heterogeneous module (hm) and lamp which indicated maintenance on all was up to date.A siemens headquarters support center specialist reviewed the event data and stated that the discordant result could be caused by a sample integrity issue or a worn probe.The cause for the falsely elevated ft4 result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
 
Event Description
A discordant, falsely elevated free thyroxine (ft4) result was obtained on a patient sample on a dimension xpand plus with hm instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated few days later on the same instrument, resulting lower and as expected for the patient.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ft4 result.
 
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Brand Name
DIMENSION XPAND PLUS WITH HM
Type of Device
CLINICAL CHEMISTRY ANALYZER
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGANOSTICS 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
cassandra kocsis
511 benedict ave
tarrytown, NY 10591
9145242687
MDR Report Key6487838
MDR Text Key72674424
Report Number2517506-2017-00381
Device Sequence Number0
Product Code CEC
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 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDIMENSION XPAND PLUS WITH HM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/21/2008
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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