MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; RP 500E

Catalog Number 11416755

Device Problem Low Test Results (2458)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

The customer reported that they received a discrepant low total hemoglobin result compared to retesting of a new sample on their laboratory instrument.There is no report of injury due to this event.

Manufacturer Narrative

The customer has provided instrument files for further investigation.Investigation is underway.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation.The rp500e instrument including the co-oximetry subunit, was found to be performing as intended.There were no system or sensor specific errors in and around the time of the patient sample in question was measured.The automatic quality control (aqc) data for the total hemoglobin (thb) parameter was stable for the duration of measurements and within reportable range.For the patient sample in question, the sensor raw responses were reviewed, and no anomalous behavior was noted.The sample passed all internal sample and end-point detection quality checks.Thb assays are also known to be highly sensitive to sample collection and handling techniques.Preanalytical factors like hemolysis and insufficient mixing, time to sampling, etc.Are known causes for imprecise thb results.The following facts were noted that cannot confirm the alleged discrepancy.The thb result from the secondary instrument was run 90 minutes prior to the alleged patient sample in question.The whole panel of parameters was not available to review to observe if the samples were comparable.While it is reported that the discrepancy was confirmed with repeat samples, there were no repeat samples run on the escalated instrument nor the data from the repeat sample was shared to review.The cause of this event is unknown.No device problem found.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18485372
• MDR Text Key: 332998750
• Report Number: 3002637618-2024-00112
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192240
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11416755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female