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

Model Number	IMMULITE 2000 XPI - AFP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.Siemens headquarters support center (hsc) is reviewing the data provided by the customer.Calibrations and quality control (qc) were all checked and are within expected limits.The cause for the discordant falsely depressed afp sample results is unknown.Siemens is investigating the issue.
Event or Problem Description
Two discordant, falsely depressed alpha-fetoprotein (afp) results were obtained using immulite 2000 xpi.The initial result was reported to the physician(s).A repeat result was obtained on immulite 2000 xpi and was considered discordant.Additional repeated results were obtained using siemens' advia centaur xp.The repeat results from advia centaur xp were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed afp results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2019-00408 on 15-nov-2019.Additional information (19-nov-2019): siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc found that the patient was diagnosed with chronic hepatitis.The immulite 2000 -afp instructions for use (ifu) indicates that patients with chronic active hepatitis may present elevated concentrations of serum afp.The assay is not intended to be used with patients who do not have nonseminomatous testicular cancer or are not being screened for maternal purposes.As the patient is neither a maternal screening patient nor a patient with nonseminomatous testicular cancer the assay is not being used in alignment with the intended use.There is no product non-conformance identified and the results were discussed with the customer and no further support was required.The instrument is performing within specification.No further evaluation of the device is required.Section(s) h6 and h10 were updated to reflect the additional information provided on 19-nov-2019.

• Brand Name: IMMULITE 2000 XPI - AFP
• Common Device Name: IMMULITE 2000 XPI - AFP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9329763
• Report Number: 2432235-2019-00408
• Device Sequence Number: 2197441
• Product Code: LOK
• UDI-Device Identifier: 00630414961033
• UDI-Public: 00630414961033
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P010007
• 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,Followup
• Report Date (Section B): 12/13/2019

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 - AFP
• Device Catalogue Number: 10381187
• Device Lot Number: 502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1