MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. NEGATIVE MIC 38

Model Number B1017-412

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

(b)(6) survey result reported false susceptible for cfz on esbl using siemens neg mic 38 panel.Test results yielded e.Coli false susceptible cefazolin (cfz) results.Proficiency isolate's expected results were resistant to cefazolin (cfz).Customer is a manual read user.There was no patient involved as this was a proficiency survey isolate.

Manufacturer Narrative

(b)(4).Compare results from expected survey results.

• Brand Name: NEGATIVE MIC 38
• Type of Device: NEGATIVE MIC 38
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; west sacramento CA 95691
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 4260709
• MDR Text Key: 4991440
• Report Number: 2919016-2014-00043
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1017-412
• Device Catalogue Number: B1017-412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1