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

Catalog Number 10697306

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.The cause for the discordant results is unknown.

Event Description

The customer reported discordant sodium values.There was no report of injury due to this event.

Manufacturer Narrative

Siemens assessed the data from rp500 sn (b)(4).The customer described the result on the rp500 as "low" and was concerned if the brand of wipes, incidin, used near the analyzer was potentially causing interference.According to available product information incidin brand wipes are hydrogen peroxide based, however there are several types available under this product name.The exact brand was not specified in the complaints.There were no system errors or fluidic events around the time the suspect sample was run.The sensor output for this sample is consistent with the result provided.There is no perturbation of the na+ sensor near the time of this sample.Aqc was within published ranges for all samples tested.There is no indication the use of incidin wipes, at the present levels, caused an interfering effect or a perturbation of the na+ sensor.Results for other available analytes were not supplied, nor questioned.There is no evidence the incidin wipes used near the analyzer caused an interfering substance or contamination of the na+ sensor at present levels.The rp500 analyzer and na+ sensor were performing typically.The minor differences in na+ results are most likely caused by methodology or sample matrix differences.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• 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: 6182737
• MDR Text Key: 63071042
• Report Number: 3002637618-2016-00170
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1