MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS

Catalog Number 10332185

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that they retest everything that is positive for any analyte.The customer stated they were not using siemens strips but will begin to use only siemen's strips going forward.Due to the fact that they haven't run qc, siemens is sending the customer bulleting with qc recommendations.They stated that they will begin using qc.The customer has agreed to purchase a replacement test table which includes the calibration bar.

Event Description

The customer reported that they have been getting multiple discrepant results.The customer's concern is that patients may have received unnecessary treatment such as given antibiotics for a uti when no infection was present.The customer stated that they are using non-siemens strips and that they have not run qc in at least eight years and the calibration bar has never been replaced.The customer confirms there has been no injury to patients based on inaccurate results.

• Brand Name: CLINITEK STATUS
• Type of Device: CLINITEK STATUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6952721
• MDR Text Key: 90223428
• Report Number: 3002637618-2017-00138
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2017

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: 10332185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 10/16/2017
• 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