MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number	10379677
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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+
• Common Device Name: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8135618
• Report Number: 3002637618-2018-00132
• Device Sequence Number: 11124952
• Product Code: JIL
• UDI-Device Identifier: 00630414572314
• UDI-Public: 00630414572314
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 10379677
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1