MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Products, Limited IMMULITE 2000 AFP; Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• Brand Name: IMMULITE 2000 AFP
• Common Device Name: Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
• Manufacturer (Section D): Siemens Healthcare Diagnostics Products, Limited; glyn rhonwy, gwynedd; uk registration #: 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): Siemens Healthcare Diagnostics Products, Limited; glyn rhonwy, gwynedd; uk registration #: 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: jennifer cacace ; 333 coney st.; east walpole, MA 02032 ; +1(802)430-2902
• MDR Report Key: 50777627
• Report Number: 1219913-2026-00176
• Device Sequence Number: 10754269
• Product Code: LOK
• UDI-Device Identifier: 00630414961033
• UDI-Public: 00630414961033
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Model Number: N/A
• Device Catalogue Number: 10381187
• Device Lot Number: Unknown
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown