FDA Adverse Event
Injury
Summary report: N
MOSAIQ
MDR report key: 7017198
·
Received November 10, 2017
Report
- Report Number
- 2950347-2017-00024
- Event Type
- Injury
- Date Received
- November 10, 2017
- Report Date
- November 10, 2017
- Manufacturer
- ELEKTA INC.
- Product Code
- IYE
- UDI-DI
- 00858164002091
- PMA / PMN Number
- K141572
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIST
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION CONCLUDED THAT THE USER WAS RECALCULATING THE DOSE AFTER APPROVAL AND DID NOT REAPPLY A DOSE ADJUSTMENT AFTER RECALCULATION. ELEKTA HAVE EXPLAINED TO THE SITE THAT DOSE ADJUSTMENTS ARE NOT MEANT TO BE PRESERVED IN THIS PROCESS. MOSAIQ IS WORKING AS DESIGNED AND INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT EACH TIME THE BSA IS UPDATED ON A PREVIOUSLY CALCULATED DOSE, THE DOSE AUTOMATICALLY DEFAULTS BACK TO THE FULL DOSE. BASED ON THE AVAILABLE INFORMATION A PATIENT RECEIVED ONE DOSE OF MEDICATION THAT WAS 25% HIGHER THAN INTENDED. DOSE ERRORS OF THIS MAGNITUDE COULD RESULT IN SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801340 | MOSAIQ | ACCELERATOR, LINEAR, MEDICAL | IYE | ELEKTA INC. | 00858164002091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |