MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265; RL 1265

Model Number	10321852
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.The requested data files for investigation have been received.The customer stated that the co-ox chamber has been replaced, the qc results were in the expected ranges and the instrument is operational.
Event or Problem Description
The customer reported discrepant total hemoglobin and hematocrit results on the rl 1265 instrument when compared to a non-siemens hematology system.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has reviewed the data provided by the customer.The rl1265 co-oximeter appeared to have correctly measured the sample in question based on what was present within the co-ox slide cell.An additional wash occurred immediately afterwards, based on the post-wash quality.This diagnostic test determined that the clarity of the co-ox slide cell after the additional wash was compromised; as a result, the system posted a d70:2 error and automatically turned off the reporting of thb/co-ox.The functionality was restored once a thb zero calibration was successful.Approximately 20 minutes later a d70:2 error again was posted (during aqc measurements).The customer replaced the co-ox module as suggestive of the diagnostic code.Based on this series of events, it is most probable that a partial clot was drawn into, or got caught directly in front of, the slide cell when the blood sample in question was fluidically moved into the co-ox slide cell.This may have prevented all the cells or restricted the flow of some of the sample from getting into the co-ox slide cell where the optical measurement occurs, resulting in a lower than expected thb value.This partial clot, or portions of it, appeared not to be successfully washed out afterwards.The monitoring diagnostic test flagged a potential issue.When comparing thb results between devices, factors that can impact observed bias include differences in matrix and measuring technology, sample mixing conditions and other differences in handling of separate samples, adequate draw volume, collection site, and cell clumping, and other pre-analytical conditions such as lipemia, icterus, and hemolysis.

• Brand Name: RAPIDLAB 1265
• Common Device Name: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9460762
• Report Number: 3002637618-2019-00131
• Device Sequence Number: 2159177
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K073537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10321852
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR