MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDCOMM DATA MANAGEMENT SYSTEM

Catalog Number 10318763

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The customer stated that the issue is with their biolink communication driver and not with rapidcomm.The customer has contacted and addressed this issue with their lis provider.

Event Description

The customer reported a mismatch between rapidcomm 6.0 and their lis on approximately 10 patients.There was no data provided by the customer.There was no reported injury due to this event.

• Brand Name: RAPIDCOMM DATA MANAGEMENT SYSTEM
• Type of Device: RAPIDCOMM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6076935
• MDR Text Key: 59132304
• Report Number: 3002637618-2016-00137
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2016

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
• Device Catalogue Number: 10318763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/03/2016
• 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
• Patient Age: 78 YR