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	05/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation led to a discussion on how to properly perform maintenance as it appears the customer was not performing maintenance as recommended.After performing correct maintenance, customer reported quality control was passing.Reagent is being requested back for further investigation.The cause of this event is unknown.
Event or Problem Description
The customer obtained false negative leukocyte results on two patients 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
Proper maintenance and technique were reviewed with no issues.Possible interferents that may cause false negative leukocytes was review with the customer.The certificate of analysis for lot in use at the time of the event was reviewed and passed all specifications upon manufacturing release.The customer returned reagent to siemens for further evaluation.Investigational testing was performed on returned reagent using three technical operations owned status + instruments.Four strips were tested per instrument, using wbc 42 cell solution (0143-77 exp 1/10/25) to represent a positive leucocyte solution.No discrepant false negative results were obtained; all 12 results were observed positive.Based on the data collected, the customer¿s report was not observed.The cause of this event is unknown.

• 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: 19397283
• Report Number: 3002637618-2024-00057
• Device Sequence Number: 7772572
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/02/2024

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: 05/13/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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