MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. LABPRO COMPUTER

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

Patient Problem Collagen disease (2189)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

The panel processing customization window in (b)(4) allows the operator to customize the 24 hour hold options for (b)(6) using dried overnight panels.Tis was discovered during current software development activities.Per the dried gram positive procedural manual.Accurate detection of resistance requires an extended incubation time of 24 hours for (b)(6) organism and (b)(6) antimicrobics.

Manufacturer Narrative

This is an internal complaint.Further investigation revealed a gap in the procedural requirements for assay and software design controls.The procedure did not make provisions to document software considerations, in addition to the algorithm.The procedure was revised to include this requirement, as well as other requirements for additional applicable detailed labeling information.For example, instructions were added for the labpro operator's guide in order to document requirements that affect the software.(b)(6).

• Brand Name: LABPRO COMPUTER
• Type of Device: LABPRO COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; west sacramento CA
• Manufacturer (Section G): BECKMAN COULTER
• Manufacturer Contact: norma rahill ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 3944058
• MDR Text Key: 16863750
• Report Number: 2919016-2014-00020
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 05/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1