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

Catalog Number 10321852

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Siemens has requested the data files to investigate this event.The cause for this event is unknown.

Event Description

The customer reported discrepant total hemoglobin results on three different rl 1265 analyzers and another siemens lab analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens investigator states that many files have been provided and uploaded, however they are either from a day other than the day of the event or the file shows as being only 1kb.Also, the investigator states from the minimal information available in the.Csv files, there was no indication that the thb result in question was flagged for any co-ox errors.Unfortunately there is not sufficient/pertinent data for r&d to review to provide a root cause of this discrepancy.Proper sampling and thorough mixing is very important for accurate thb results.To appropriately mix red blood cells, whole blood specimens need to be mixed in several planes (rolling back-and-forth and circular top-over-bottom and/or figure-8 style).

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Type of Device: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7314004
• MDR Text Key: 101721381
• Report Number: 3002637618-2018-00020
• Device Sequence Number: 0
• Product Code: GKR
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR