MAUDE Adverse Event Report: ELEKTA, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problem Application Program Problem: Dose Calculation Error (1189)

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

Event Type  No Answer Provided  

Event Description

Patient carboplatin doses are being miscalculated utilizing the electronic order entry system, mosaiq, due to non-standard height, weight and serum creatinine units in a manual provider entry pop-up box.Mosaiq software triggers a pop-up data entry box for carboplatin doses when current height, weight and creatinine are out-of-date.The pop-up box forces providers to choose between entering data in english imperial units (height in inches, weight in pounds, and serum creatinine in mg/dl) or si units (height in centimeters, weight in kilograms, serum creatinine units are mol/l).There is no way for a provider to enter a patient's height in centimeters, weight in kilograms, and serum creatinine in mg/dl.Carboplatin dose is typically calculated using the calvert calculation.This calculation uses creatinine clearance in milliliters per minute plus 25, times the goal auc.The carboplatin dose must be 'capped' at a maximum creatine clearance of 125ml/min.Since 2020, there have been at least four patients where the provider entered the patient's creatinine measured as mg/dl in the si box labeled mol/l.This leads to creatinine clearances over 4,000 ml/min and erroneous carboplatin capping errors.Thankfully, our pharmacy team caught these issues during initial dose preparation, and none of these incorrect doses were administered.We called mosaiq in 2020 about this concern, but they stated there is nothing they can do to improve this situation.They didn't seem to believe that in the u.S.We use units of kg, cm, and mg/dl.After numerous requests, mosaiq will not remove the box to fix this issue.Ultimately, we are stuck without the ability to make a change to the system to fix this issue and rely on our pharmacists to catch these unnecessary mistakes.Our staff is highly concerned about the continuation of carboplatin dosing miscalculations.I would like mosaiq to take another look at this issue in order to prevent harm to patients.Contributing factors: facility computer entry error prescription processing software computer physician order entry.Special code: oncology drug.Severity: error occurred; medication did not reach pt.(b)(6).(b)(4).

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA, INC.
• MDR Report Key: 12532369
• MDR Text Key: 273649049
• Report Number: MW5104191
• Device Sequence Number: 1
• Product Code: IYE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1