MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. - GLASGOW STRATUS CS

Catalog Number 10453571

Device Problem High Test Results (2457)

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

Event Date 01/05/2014

Event Type  Other  

Event Description

Customer reported discordant troponin results on the instrument.There was no report of injury due to this event.

Manufacturer Narrative

Customer indicated that instrument displayed errors attributed to a tip being jammed on the probe after processing the samples on the instrument.Customer also indicated that they cleared error according to the operators guide and instrument is performing to expectations.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC. - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC. - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19702
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3641833
• MDR Text Key: 22265130
• Report Number: 1217157-2014-00017
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2014

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: Health Professional
• Device Catalogue Number: 10453571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1