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

Catalog Number 10697306

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens is in process of evaluating the event.Customer has been requested to provide additional files to investigate the event.The root cause for the event is unknown.

Event Description

Customer stated that instrument reported 3 falsely elevated sodium results compared to alternate instrument.There was no report of injury due to this event.

Manufacturer Narrative

There is evidence of benzalkonium interference routinely throughout the use life of the cartridge installed on sn (b)(4).Benzalkonium is a known interfering substance as listed in the rp500 operator's manual.The sensor had been exposed numerous times throughout the use of this cartridge causing intermittent na calibration errors.The source of the contamination should be investigated and eliminated.There were no system or sample errors occurring on instrument (b)(4) on (b)(6) when the suspect samples were run.There were differences in recovery on na, k, cl, thb and lactate suggesting pre-analytical factors.

• 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: 5703634
• MDR Text Key: 48001865
• Report Number: 1217157-2016-00063
• Device Sequence Number: 1
• Product Code: GKR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10697306
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1