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

Catalog Number 10697306

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Death (1802)

Event Date 05/02/2014

Event Type  Death  

Event Description

Customer reported that the rp500 instruments displayed question values [.?] for sodium (na), potassium (k), and calcium (ca) on a patient sample and the instrument did not report any results for these analytes.Customer indicated that a blood gas sample was collected from a resuscitated patient on (b)(6) 2014.Customer indicated that they repeated the measurement on the same system(s/n (b)(4)) and another rp500 system(s/n (b)(4)) and both systems displayed question values [.?] for sodium (na), potassium (k), and calcium (ca) and the systems did not report any results for these analytes.Customer indicated that approximately 10 minutes later, they measured a sample on their rl1265 blood gas system and results for the all the analytes were generated including sodium (na), potassium (k), and calcium (ca).Customer mentioned that patient died but not because of the rp500 displayed question values [.?] for sodium (na), potassium (k), and calcium (ca) and it did not report results for these analytes.

Manufacturer Narrative

This event is under investigation.Device manufacture date for serial no.(b)(4) is 09/26/2013.Device manufacture date for serial no.(b)(4) is 09/28/2013.

Manufacturer Narrative

Customers have been notified about this situation.Urgent field safety notice 31512 rev a was issued for distribution on 27 may 2014.

• 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: 3811899
• MDR Text Key: 4471765
• Report Number: 1217157-2014-00067
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10697306
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2014
• Date Device Manufactured: 09/26/2013
• Is the Device Single Use?: No
• Removal/Correction Number: 1217157-05-20-2014-003-C
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR