MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+ USA

Catalog Number 10379675

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The customer stated that they run controls once a week and the controls were within range.The correct technique was gone over with the customer and it is stated that they are using the correct technique.The cause for this event is unknown.

Event Description

The customer reported false negative leukocytes.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+ USA
• 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: 6223650
• MDR Text Key: 64176712
• Report Number: 3002637618-2017-00002
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1