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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer stated that proper technique and maintenance was performed.No urinalysis was performed on the patient sample, and it is no longer available for return.Siemens has requested that the remaining reagent from the lot in question be returned for further investigation.The cause of this event is unknown.
Event or Problem Description
The customer stated that they received a false negative hcg result on one patient from their status+ analyzer compared to retesting of the same sample on the same instrument.The customer stated the positive result was confirmed by a scan.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has completed the investigation.Testing was performed on returned reagent using three in-house status+ instruments.Testing was completed using a pooled negative urine and a urine solution contrived to a 25miu/ml hcg target, the minimum concentration listed in the customer insert for a positive determination.No false negative results were reported.Based on the data collected, the customer report of false negative hcg result was not observed.Proper technique and maintenance were reviewed with the customer.Rsc indicated that an issue with technique was identified.Customer is also unsure if start button is pressed prior to dispensing sample into the cassette and did not share how the calibration bar is cleaned.The certificate of analysis for the lot in use at the time of the event indicates that it met specifications at the time of manufacturing release.The cause of this event is likely due to user error.

• 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; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17862139
• Report Number: 3002637618-2023-00078
• Device Sequence Number: 6183248
• Product Code: JHI
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/07/2024

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: 09/13/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female