MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Model Number	10636672
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11679089
• Report Number: 3002637618-2021-00027
• Device Sequence Number: 16917985
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K063276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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 Model Number: 10636672
• Device Catalogue Number: 10636672
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1