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

Catalog Number 10379675

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer indicated that they did not have urine or same bottle of strips to return for investigation.Customer has not had any further leukocytes issues.The cause for the false negative leukocytes result is unknown.

Event Description

Customer reported false negative leukocytes result on the analyzer.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 5214531
• MDR Text Key: 30910754
• Report Number: 1217157-2015-00161
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1