MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379677

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens reviewed maintenance and cleaning procedures with the customer.In addition, their sample handling and process technique were reviewed.There were no issues found.The calibration bar was recently cleaned as per procedure.Siemens will provide the customer with a loaner system to run a side by side comparison with their own system and an update will be provided once completed.The cause of this event is unknown.

Event Description

The customer reported three patients with false negative and one patient with small leukocyte results on the clinitek status+ when compared to the manual microscopy reading.There was no report of injury due to this event.

Manufacturer Narrative

As stated in the initial report - 3002637618-2018-00132: "siemens will provide the customer with a loaner system to run a side by side comparison with their own system." there is no indication that this has been done.After several inquiries, there has been no response from the customer regarding a side by side comparison.Siemens service went onsite and reviewed proper maintenance and technique with the customer.The customer was not using proper technique.Siemens has provided further training for this customer.The customer stated that they frequently have urine samples too small for the correct dipping technique and their only option is to use a dropper.Siemens has no official recommendations for using a dropper to apply the sample to the strip.A review of this lot of mutistix 10 sg reagent has shown no similar complaints.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8135618
• MDR Text Key: 129587159
• Report Number: 3002637618-2018-00132
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414572314
• UDI-Public: 00630414572314
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• 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: 02/04/2019

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: 10379677
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1