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

Catalog Number 10492730

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer should not have run patient samples when aqc was turned off on the instrument.Customer confirmed that they did not see any deviation in results.Customer was aware of the security setting features to prevent the operator from turning off aqc.Siemens published a customer bulletin on (b)(6) 2014 which states that when an operator disables the automatic qc option, and then fails to reselect and save the aqc option in the setup, no qc will be run automatically, and there are no indications on the analyzer display to notify the operator that the automatic qc has been disabled.A copy of customer bulletin has been provided to the customer.The event had occurred due to an operator error.

Event Description

Customer reported that they did not run automatic quality control (aqc) from (b)(6)2015.Customer indicated that 256 patient samples were run during that timeframe.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industry; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4924912
• MDR Text Key: 22507220
• Report Number: 1217157-2015-00102
• Device Sequence Number: 1
• Product Code: KQO
• 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
• Report Date: 06/26/2015

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
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1