MalfunctionIWG
THERASEED PALLADIUM 103 ISOTOPE
Received Apr 14, 1999
Report MW1016130 · MDR key 219121
Device
Generic name
Implant For Prostate Cancer
Manufacturer
Theragenics Corp.Model number
*Catalog number
*
Lot number
9914F
Product problems
- Calibration Error
- Off-Label Use
Patient
*
Narrative
Description of Event or Problem
TWO SHIPMENTS WERE RECEIVED, EACH HAVING A DIFFERENT LOT NUMBER. SHIPMENT A CONTAINED THE CALIBRATION SEED FOR SHIPMENT B, AND SHIPMENT B CONTAINED THE CALIBRATION SEED FOR SHIPMENT A. IF THE PROBLEM HAD NOT BEEN NOTICED, PTS WOULD HAVE BEEN UNDERDOSED OR OVERDOSED BY 30% DEPENDING ON WHICH LOT NUMBER THEY RECEIVED. THE FACILITY USED THEIR OWN CALIBRATION SEED. THE PROBLEM WAS REPORTED TO THE MFR, BUT THE MFR JUST SAID THAT THE WRONG CALIBRATION SEED GOT IN THE WRONG SHIPMENT.