MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1265 BLOOD GAS ANALYZER; RL1265

Model Number 10321852

Device Problem Non Reproducible Results (4029)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.No patient treatment was affected due to the discrepant results.Siemens has requested instrument log files for investigation.The cause of this event is unknown.

Event Description

The customer reported several discrepant thb results on their rl1265 instrument compared to retesting of different samples on a non-siemens hematology instrument.There is no report of injury due to this event.

Manufacturer Narrative

The customer was not able to provide instrument files.Without files, siemens cannot perform a proper investigation and therefore the root cause of the customer issue cannot be determined.Siemens has provided the customer with instrument comparison studies and service has reiterated the importance of sample handling.The customer has declined to perform their own internal correlation study for siemens to evaluate.However, they have accepted the recommendations for sample handling and pre-analytics.The cause of this event is unknown.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Type of Device: RL1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10461496
• MDR Text Key: 205572274
• Report Number: 3002637618-2020-00045
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (y/n): N
• PMA/PMN Number: K073537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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
• Device Model Number: 10321852
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1