MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1245; RL 1245

Catalog Number 10321844

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens representative explained to customer that once a sample has been validated it can be reassigned using patient->directory screen first add the patient to the patient record then reassign the patient.Customer confirmed that the incorrect patient id was changed in the analyzer to the correct patient id and the results process through rapidcomm and that the system is operational at this time.Issue is resolved and system operational.No further action or assistance required of technical support.The cause of the malfunction was determined to be an operator error.

Event Description

Customer reported that they scanned wrong barcode and sample in the validation que was incorrect.Customer wanted to know if the patient information could be corrected at the analyzer.There was no report of injury due to this event.

• Brand Name: RAPIDLAB 1245
• Type of Device: RL 1245
• 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: 5028066
• MDR Text Key: 24804435
• Report Number: 1217157-2015-00120
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031560
• 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
• Report Date: 07/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10321844
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1