MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS 10-WAY REAGENT PAK

Catalog Number 10311120

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The issue was resolved by the siemens customer service (cse).Cse performed standard troubleshooting on the instrument which includes cleaning the heat filter lens.System is operational.

Event Description

Customer reported 4 false negative leukocytes results on the instrument whereas alternate instrument reported moderate results for leukocytes.There was no report of injury due to this event.

Manufacturer Narrative

Customer reported 4 false negative blood results (and not leukocytes) on the instrument whereas alternate instrument reported moderate results for blood (and not leukocytes).

• Brand Name: CLINITEK ATLAS 10-WAY REAGENT PAK
• Type of Device: CLINITEK ATLAS 10-WAY REAGENT PAK
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SPARTON MEDICAL; 22740 lunn road; cleveland OH 44149
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6113689
• MDR Text Key: 60858481
• Report Number: 3002637618-2016-00155
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00630414373003
• UDI-Public: 00630414373003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

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: Medical Technologist
• Device Catalogue Number: 10311120
• Device Lot Number: 1A707086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1