MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. POCCELERATOR DATA MANAGEMENT SYSTEM

Catalog Number 10732871

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

After reviewing the information provided by the customer, siemens determined that the instrument was operating as intended.The customer had set up their instrument to have a default patient id stored in their assigned patients.This is a feature of the device to be enabled when the device will be used for only one patient, and is outlined in the instrument manual.The customer has been advised that to resolve this issue they must disable this feature.

Event Description

The customer reported that when they run a test on their rapidlab analyser without entering a patient id and the results were processed by poccellerator, the result will automatically be assigned a patient id.It is always the same patent id.The customer has not confirmed if the patient id assigned is for an actual patient.There is no report of injury due to this event.

• Brand Name: POCCELERATOR DATA MANAGEMENT SYSTEM
• Type of Device: POCCELERATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: tom myers ; 2 edgewater dr; norwood, MA 02062
• MDR Report Key: 15086815
• MDR Text Key: 304611760
• Report Number: 3002637618-2022-00050
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: 57967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10732871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• 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: Unknown
• Patient Sequence Number: 1