MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Model Number 10636672

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results.Siemens has requested additional information several times but to date, has not been received.Technique, cleaning and maintenance have been discussed with the customer.Troubleshooting steps have been provided to the customer.The customer has agreed to perform these steps.The cause of this event is unknown.

Event Description

The customer reported a false negative leukocyte on one patient's urine sample on the clinitek advantus when compared to the visual read of the multistix 10 sg and the microscopic exam of the urine sediment.There is no report of injury due to this event.

Manufacturer Narrative

Siemens received a response, from the customer in regards to providing additional information.And performing troubleshooting and an investigation: the sample has been discarded and the strips are now expired.Proper technique and maintenance are regularly performed.Qc is consistently in the expected range.The customer will watch for any other similar occurrences.The customer stated, they are satisfied.And no further action is required from siemens.No investigation will be performed.The cause of this event is unknown.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11679089
• MDR Text Key: 247968975
• Report Number: 3002637618-2021-00027
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (y/n): N
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10636672
• Device Catalogue Number: 10636672
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1