MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 HCG

Model Number IMMULITE 2000 HCG

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.A water test was performed, the system was decontaminated, and qc was rerun, recovering in range.Siemens is investigating the issue.

Event Description

Erroneous, falsely elevated human chorionic gonadotropin (hcg) results were obtained on patient samples on an immulite 2000 xpi system using immulite 2000 hcg reagent.The patients were invitro fertilization (ivf) patients, and lower hcg results were expected as the patients were not pregnant.The samples were repeated on a non-siemens analyzer, recovering lower.The lower results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated hcg results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2024-00001 on 05-jan-2024.Additional information on (31-jan-2024): quality controls (qc) recovered in range on the day of the event but also showed a slight positive bias.Troubleshooting by the customer included performing a water test which was negative for contamination.A siemens customer service engineer (cse) was dispatched to customer's site.The cse checked the aligned the probes and replaced the dual resolution dilutor (drd) seal, spring, and water filter.Hcg precision was verified following the service actions, and the precision was acceptable.This customer is operational, and the reported issue was resolved by standard service actions.The investigation findings and investigation conclusions codes in section h6 were updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: IMMULITE 2000 HCG
• Type of Device: IMMULITE 2000 HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 18454637
• MDR Text Key: 332739791
• Report Number: 1219913-2024-00001
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IMMULITE 2000 HCG
• Device Catalogue Number: 10381206
• Device Lot Number: 478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1