MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDCOMM DATA MANAGEMENT SYSTEM; RAPIDCOMM 3.0

Catalog Number 10379866

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

The customer has multiple facilities connecting to one rapidcomm data management system.Each facility used it's own patient id consisting of nine digits, eight numeric and one alpha.The alpha digit is to denote each unique facility.The site set up rapidcomm, to populate the patient id as a medical record number without the alpha character and only using the eight numeric digits.This resulted in a non-unique patient identifier in rapidcomm.The discrepancy was noticed prior to sample validation, so no patient care was affected.The sample was processed manually and the physician was given the correct patient results.

Event Description

The customer reported the sample data from one patient was mapped to a different patient in rapidcomm.There was no report of injury due to this event.

• Brand Name: RAPIDCOMM DATA MANAGEMENT SYSTEM
• Type of Device: RAPIDCOMM 3.0
• 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: 6648446
• MDR Text Key: 77844303
• Report Number: 3002637618-2017-00099
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/16/2017

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: 10379866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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