MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500; RP500

Catalog Number 10697306

Device Problem Low Test Results (2458)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Customer reported discrepant low thb (total hemoglobin) results for a patient sample that was analyzed on their rp500 instrument when compared to the thb results when a new sample was tested on a non-siemens instrument.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has requested the instrument log files for further investigation.Investigation is ongoinng the cause of this event unknown.

Manufacturer Narrative

Siemens has completed the investigation.A review of the instrument data provided by the customer showed a d39 obstruction error, d70:2 optical error and frequent occurrences of additional wash required, more d70:2 errors, d2 excessive drift, and d3 slope errors for thb.Consequently, thb was disabled several times.This sequence of events is an indication of an optical clarity issue such as presence of bubble in wash process.The source of bubble is unknown.Co-oximetry optical subsystem responsible for the measurement of thb appeared stable with constant temperature and in control during the sample measurements.Definitive root cause could not be determined.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; northern road; chilton industrial estates; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 15540734
• MDR Text Key: 306359370
• Report Number: 3002637618-2022-00062
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122539
• 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,Followup
• Report Date: 10/27/2022

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: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 72 YR
• Patient Sex: Female