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

Catalog Number 10321788

Device Problem False Negative Result (1225)

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

Event Date 11/13/2014

Event Type  No Answer Provided  

Event Description

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

Manufacturer Narrative

Customer indicated that all other parameters on the instrument were reported correctly.Customer also indicated that this was the only patient sample that had been shown to exhibit this issue.The cause for the false negative leukocytes results is unknown.

Manufacturer Narrative

Investigation into the customer's returned reagent strips is complete.Siemens technical operation team was unable to reproduce the customer's issue.

• 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: 4309673
• MDR Text Key: 5275019
• Report Number: 1217157-2014-00185
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

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: Other
• Device Catalogue Number: 10321788
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1