MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDCOMM V4.0

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The customer has multiple unique locations that use their own independent mrn(medical record number) generation system.- the customer's multiple locations have the potential to create the same mrn at different sites, therefore a potential for duplicate mrns is possible due to the customers process.- the customer uses mrn as the patient id/sample id for their blood gas samples at each location.- they use rapidcomm as a conduit to transfer the blood gas results from the rp500s at each site to their cerner lis.- rapidcomm uses the mrn as the default primary identifier, since mrn at medical facilities are unique.- siemens customer care center (ccc_ts) has advised the customer to a unique mpi # generated by cerner as the primary identifier and not the mrn.Cc-ts explained to the customer to change rapidcomm's primary record identify selection to "alternate patient id" which in this case would be cerners mpi and there would be no primary identifier conflict going forward.The customer was advised this would resolve their issue.The event has occurred due to an operator error.

Event Description

Customer reported that rapidcomm displayed male patient results on a female patient and it happened 6 time since (b)(6) samples ((b)(6) 2016 ran on rp500 (38187) and samples ((b)(6) 2016 ran on rp500(38211)).There was no report of injury due to this event.

• Brand Name: RAPIDCOMM V4.0
• Type of Device: RAPIDCOMM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 5908093
• MDR Text Key: 54156443
• Report Number: 1217157-2016-00091
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/26/2016

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 Health Care Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1