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

Catalog Number 10492730

Device Problem Product Quality Problem (1506)

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

Event Date 05/31/2014

Event Type  malfunction  

Event Description

The customer reported that they restored quality control(qc) parameters after automatic quality control(aqc) level 2 and level 3 failed on the instrument during 2pm and10pm on (b)(6) 2014.Customer also reported that 8 patient samples (5 of them only for pco2 and 3 of them for full gas results) were run during this timeframe.

Manufacturer Narrative

Customer should not have restored the quality control and run patient samples when the automatic quality control(aqc) level 2 and level 3 failed on the instrument.Customer indicated that during the time that the ph had been restored, 3 samples with ph results were run and reported.Siemens representative requested customer to check and determine if ph results were questioned and if patient treatment was affected.Customer has not responded back at this point.Customer spoken to the siemens representative about the "restore qc" feature and changed the security assignment for all routine operators to level 4 in a restricted system so they will no longer have access to the feature.The event has occurred due to an operator error.

• 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 industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3907161
• MDR Text Key: 4654290
• Report Number: 1217157-2014-00092
• Device Sequence Number: 1
• Product Code: KHP
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• 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
• Date Manufacturer Received: 06/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1