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

Catalog Number 10492730

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens is in process of investigating this event.The cause for the event is unknown at this moment.

Event Description

Customer reported analyzer populated operator id on the patient id field on the demographic screen while running blood samples.Customer indicated that on (b)(6) 2015; they were running blood samples after installing new measurement cartridge and noticed that her operator id ((b)(6)) populated on the patient id field before scanning or typing anything on the patient id field.There was no report of serious injury due to this event.

Manufacturer Narrative

Siemens software engineering team reviewed the complaint and was unable to reproduce the event.Customer has not indicated any additional occurrences.There also have not been any previous documented occurrences of the event.

• 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: 5068858
• MDR Text Key: 26114663
• Report Number: 1217157-2015-00131
• 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,user f
• Reporter Occupation: Respiratory Therapist
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• 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: 10/02/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR