MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained false negative leukocyte results on one patient compared to retesting on their laboratory instrument.Repeat testing was performed from the same sample.Time between tests was not provided.There is no report of injury due to this event.
Additional Manufacturer Narrative
Initial investigation led to a discussion on proper maintenance.The customer is performing maintenance as described in the operator's guide.The calibration bar was inspected following the event and appeared clean and normal.Proper technique was discussed and confirmed to be used by the operators.Quality control (qc) is run every 30 days.Qc was passing prior to the event and following the event.Reagent is being requested back for further investigation.The cause of this event is unknown.
Additional Manufacturer Narrative
Siemens showed due diligence in getting the complaint reagent back for investigation, however, to date, there have not been any information regarding the complaint reagents and no other information has been provided.Without the returned reagent, further investigation cannot proceed and therefore the root cause cannot be determined.Without a further investigation, 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.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 20194626
• Report Number: 3002637618-2024-00093
• Device Sequence Number: 6880476
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: (01)00630414574639
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 11/05/2024

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: 08/27/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown