MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS+; CT STATUS+

Catalog Number 10379675

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/16/2014

Event Type  malfunction  

Event Description

Customer received discrepant results for nitrite (nit) and leukocytes (leu/wbc) for one patient.

Manufacturer Narrative

Customer was provided proper cleaning techniques and directions to run quality controls when initial technical call was placed.Customer has been unwilling to provide additional information.

Manufacturer Narrative

The initial mdr 1217157-2014-00117 was filed with fda on august 13, 2014.Additional information: on 08/18/2014, customer confirmed that patient was symptomatic and doctor had treated patient accordingly.Customer indicated that one other patient yielded a negative result for nitrite and was later confirmed in the lab as a positive result.On 08/25/2014, customer stated that instrument has been working fine as of late and no issues have been reported with results.Customer indicated that they ran qc on instrument and that all results were in range.Customer also indicated that they would continue to run qc on the analyzer.Siemens representative explained to the customer that siemens recommends running qc every time a new bottle of test strips is opened.Customer stated that she is satisfied with instrument.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; manufacturing, ltd.; northern road; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4006502
• MDR Text Key: 4689842
• Report Number: 1217157-2014-00117
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1