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

Model Number	IMMULITE 2000 XPI - HVG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: IMMULITE 2000 XPI - HVG
• Common Device Name: IMMULITE 2000 XPI - HVG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; UK LL55 4EL
• MDR Report Key: 10062409
• Report Number: 2432235-2020-00288
• Device Sequence Number: 3573984
• Product Code: LGC
• UDI-Device Identifier: 00630414999784
• UDI-Public: 00630414999784
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K010878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: IMMULITE 2000 XPI - HVG
• Device Catalogue Number: 10381333
• Device Lot Number: 350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1