MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ CLINITEK STATUS+

Catalog Number	10379675
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has stated that they were performing proper maintenance and passing quality controls.Siemens has requested return of reagent for further investigation.Investigation will commence once siemens receives the materials.The cause of this event is unknown.Another mdr will be filed against the second status+ instrument sn (b)(6), which also provided a false negative result.
Event or Problem Description
The customer reported that they received a false negative hcg result on their clinitek status+ instrument compared to serum testing.The patient's pregnancy was confirmed from repeat testing.There is no reported injury due to this event.
Additional Manufacturer Narrative
The event was evaluated, and the cassettes were returned for further investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Siemens completed the investigation of the false negative results from hcg result.The investigation was unable to reproduce the customer's complaint using the returned reagent.Customer stated that quality control is passing, and they are operational.The cause of the event is unknown.No product problem identified.

• Brand Name: CLINITEK STATUS+
• Common Device Name: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 21167581
• Report Number: 3002637618-2025-00006
• Device Sequence Number: 14537058
• Product Code: JHI
• UDI-Device Identifier: 00630414574639
• UDI-Public: (01)00630414574639
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K091216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2025

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 Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/19/2025; 04/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/17/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female