MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK 500

Catalog Number 10316028

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The cause for the false negative leukocytes results is unknown.

Manufacturer Narrative

Siemens technical operation team investigated returned reagent and two bottles of multistix 10sg.Based on the investigation data, the false negative leukocytes results were not reproduced.

• Brand Name: CLINITEK 500
• Type of Device: CLINITEK 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): KIMBALL ELECTRONICS (WALES) LIMITED; bridgend industrial estate; western avenue; bridgend, south wales CF31 3TY; UK CF31 3TY
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4042471
• MDR Text Key: 18039926
• Report Number: 1217157-2014-00121
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10316028
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1