MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK ADVANTUS

Catalog Number 10484765

Device Problem False Negative Result (1225)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

The customer received a false negative blood result on their clinitek advantus instrument compared to manual microscopy of the same sample.The sample was collected the day before testing and stored at room temperature.There is no report of injury due to this event.

Manufacturer Narrative

The customer stated that the sample was collected 24hrs prior to testing and stored at room temperature.Per the reagent instructions for use, "mix the sample before testing and test it within two hours after voiding.If unable to test within the recommended time, refrigerate the specimen immediately and let it return to room temperature before testing." the cause of this event is due to improper sample handling.

Manufacturer Narrative

As the customer has clarified that a test had been run the same day and the sample was not left overnight at room temperature prior to this, siemens no longer has reason to believe the discrepancy is due to user error.Siemens has requested that the customer return remaining reagent in use at the time of the event for further investigation.Investigation will commence once product has been received.The cause of this event is unknown.

Event Description

Customer clarified that another test had been performed on their advantus instrument the same day as the sample was collected that also produced a false negative result.

Manufacturer Narrative

Siemens has obtained returned reagent from the customer and completed the investigation.The customer only was able to return one of the lots in use at the time of the event, lot 305040, for investigation.(b)(4) test strips were testing using samples with positive blood and no false negative results were obtained.The customer's allegation was not observed.The cause of this event is unknown.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): KIMBALL ELECTRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne 62080 ; PL 62080
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18552166
• MDR Text Key: 333361335
• Report Number: 3002637618-2024-00002
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 10484765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 07/16/2024
• Supplement Dates FDA Received: 03/22/2024; 07/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male