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

Catalog Number 10492730

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 06/07/2014

Event Type  malfunction  

Event Description

Customer reported that automatic quality control(aqc) was deselected in the setup on the instrument during (b)(6) 2014.Customer also reported that patient samples were run during this timeframe.There was no report of injury due to this event.

Manufacturer Narrative

Customer should not have run patient samples when automatic quality control (aqc) was turned off on the instrument.Customer confirmed that no patient results were questioned during this time frame and no treatment was affected.Siemens has issued siemens knowledge base (skb) in order to inform customers to turn automatic quality control (aqc) back on before running patient samples on the instrument.The event has 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: 3912367
• MDR Text Key: 4663344
• Report Number: 1217157-2014-00097
• Device Sequence Number: 1
• Product Code: KQO
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2014

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: 10492730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: No
• 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