MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500

Catalog Number 10697306

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Customer updated rapidcomm with the correct results with the correct patient.Instrument and data management system are performing as intended.Event has occurred due to an operator error.

Event Description

Customer reported that on (b)(6) 2016 at 19:28, customer scanned the wrong patient barcode with the blood sample.Customer indicated that results crossed over to rapidcomm (data management system) under the wrong patient id (b)(6) (accession number(b)(6)).Customer confirmed that there was no report of serious injury due to this event.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• 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: 5936594
• MDR Text Key: 54686514
• Report Number: 1217157-2016-00100
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113216
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR