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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - HVG

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - HVG Back to Search Results
Model Number IMMULITE 2000 XPI - HVG
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
The customer contacted siemens customer care center.A field service engineer (fse) was dispatched to the customer site.The fse inspected the component of the instrument and found them to be working as intended.The fse found that the instrument probes are not periodically replaced, but only if needed due to damage.No other issues have been reported by the customer post the service visit.Siemens headquarters support center (hsc) reviewed the information provided.The hsc found that the instrument is operational, and the customer did not report discordant results since the initial issue.The hsc did not identify a product problem.The hsc found that there is insufficient information to determine the cause of the (b)(6) results and could not rule out pre-analytical factors or sample issue.The cause for the (b)(6) sample result is unknown.The instrument is performing within specification.No further evaluation of the device is required.
 
Event Description
One discordant, false negative result was obtained with (b)(6) on immulite 2000 xpi.The initial result was not reported to the physician(s).The sample was repeated using the same immulite 2000 xpi.The repeat result was considered correct and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the (b)(6) result.
 
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Brand Name
IMMULITE 2000 XPI - HVG
Type of Device
IMMULITE 2000 XPI - HVG
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
glyn rhonwy
llanberis, LL55 4EL
UK  LL55 4EL
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
glyn rhonwy
uk registration #: 3002806944
llanberis, LL55 4EL
UK   LL55 4EL
Manufacturer Contact
mardochee timolien
511 benedict avenue
tarrytown, ny 
5242503
MDR Report Key10062409
MDR Text Key218735933
Report Number2432235-2020-00288
Device Sequence Number1
Product Code LGC
UDI-Device Identifier00630414999784
UDI-Public00630414999784
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K010878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Model NumberIMMULITE 2000 XPI - HVG
Device Catalogue Number10381333
Device Lot Number350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2020
Initial Date FDA Received05/15/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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