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

Model Number IMMULITE 2000 XPI - AFP

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

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 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.

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
• Type of Device: IMMULITE 2000 XPI - AFP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9329763
• MDR Text Key: 219294042
• Report Number: 2432235-2019-00408
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00630414961033
• UDI-Public: 00630414961033
• Combination Product (y/n): N
• PMA/PMN Number: P010007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1