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

Catalog Number 10696855

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 12/25/2014

Event Type  No Answer Provided  

Event Description

Customer reported that in neonatal unit, ph and pco2 results on the instrument were not accurate and were not with the clinical status of the baby that the sample was taken from.Customer additionally indicated that po2 results were also discordant.Customer indicated that they were using 1ml dry lithium heparin syringes.Customer indicated that calibration and qc results from their rp-500 were stable and accurate.There was no report of injury due to this event.

Manufacturer Narrative

Siemens customer product support (cps) team investigated the complaint and concluded that suspect results cannot be confirmed as discrepant with the information provided.The gap in sample times and discrepancy around the use of syringe devices vs.Capillary devices suggest the discrepancy may be due to pre-analytical factors.The rapidpoint 500 analyzer, sn (b)(4) had ph, pco2 and po2 calibrations that were acceptable during the period of time surrounding the two events.In addition, all aqc samples for the period of time surrounding the two events were within acceptable published ranges.For both samples there were substantial time gaps between the two analyzer analysis times, which is not advised when analyzing patient samples for accurate gas results.In addition, the discrepancy between the samples being collected in syringe mode, yet tested in capillary mode on the rapidpoint suggests a transfer of the sample to a capillary device which is also not advised when handling a sample for accurate gas results.Siemens representative indicated that he tried to teach customer the right way to take capillary sample but it was a large team and not all were following the instructions the event 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 industry; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4484559
• MDR Text Key: 5495748
• Report Number: 1217157-2015-00012
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2015

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: 10696855
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/04/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1