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

Catalog Number 10444834

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation and additional information received, siemens medical affairs identified this issue as low health risk (lhr) on (b)(6) 2015.As per procedure, siemens did retrospective review of all associated complaints with this issue and identified those with potential safety issues for which medical device reports need to be filed.Siemens is revising the affected acute care testpak, calpak, and dilpak labeling to resolve this issue.Siemens issued an urgent field safety notice (33714 rev.A) to notify affected siemens customers about this issue in november 2015.

Event Description

Customer stated that she tried to scan both ctni test pak and myoglobin test paks and observed barcode not read message.There was no report of injury due to this event.

• 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; newark DE 19702
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5258700
• MDR Text Key: 32465286
• Report Number: 1217157-2015-00176
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2015

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: 10444834
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1217157-11-05-2015-005-C
• Patient Sequence Number: 1