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

Catalog Number 10309477

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017); Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

Customer reported data management software(wam rule) erroneously converted instrument's 300mg/ml protein results to 3+ and protein result 3+ converted to 1+ when it passed through wam rule of an another attached instrument.There was no report of injury due to this event.

Manufacturer Narrative

Siemens technical solution team checked the instrument and found out that instrument was performing as intended by sending 300mg/dl traceable through to the wam(data management software) but the rule converting the instrument's result to 3+ was incorrect.Customer indicated that instrument was reporting correct result but the wam rule(data management software) converting the instrument result to 3+ was incorrect.Based on the information provided by the siemens technical solution team, issue was associated with 2 pro rules.(1)wam rule(atpro03) states if pro is 0-30 then "1+".(2)wam rule(atpro05) states if pro is 101-300 then "3+".Siemens technical solution team changed the wam rule(atpro03) range which now states '1+" if pro is 29-31 so the second pass of the rules, the "3+" would not fall into any range and remain the same.The issue has been resolved after making the change in the wam rule( atpro03).

• Brand Name: CLINITEK ATLAS
• Type of Device: CT ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 3722385
• MDR Text Key: 4230598
• Report Number: 1217157-2014-00047
• Device Sequence Number: 1
• Product Code: KQO
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2014

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 Health Care Professional
• Device Catalogue Number: 10309477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1