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

Catalog Number 10492730

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer should not have restored and run patient samples when aqc was out of range for ph parameter on the analyzer.The cause of the event was determined to be an operator error.

Event Description

Customer reported that 6 patient samples were run, when automatic quality control (aqc) was out low for ph parameter on the analyzer.Customer indicated that operator restored the ph parameter and tried to run external qc but did not scan it in so it was not evaluated against any ranges.Operator ran patient samples while ph was out low for automatic quality control 3 (aqc 3).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: 5350505
• MDR Text Key: 35688220
• Report Number: 1217157-2016-00006
• 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
• Type of Report: Initial
• Report Date: 01/07/2016

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
• Device Catalogue Number: 10492730
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2015
• Initial Date FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1