TYMLOS SINGLE PATIENT-USE PREFILLED PEN
Report
- Report Number
- 3012498539-2021-00001
- Event Type
- Malfunction
- Date Received
- July 8, 2021
- Date of Event
- June 9, 2021
- Report Date
- June 9, 2021
- Manufacturer
- RADIUS HEALTH, INC.
- Product Code
- NSC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS MALFUNCTION REPORT HAS BEEN PREPARED FOR A PRODUCT COMPLAINT (B)(4). ON (B)(6) 2021, THE PATIENT INITIALLY REPORTED TO RADIUS THAT SHE WAS UNABLE TO PRIME HER PEN (LOT # RT04102). THE PATIENT DID NOT REPORT ANY ADVERSE EXPERIENCE. ON (B)(6) 2021, DURING INSPECTION OF THE RETURNED SAMPLE, RADIUS-QA OBSERVED AN ISSUE WITH THE DOSING MECHANISM. THE COMPLAINT WAS UPDATED AS A DEVICE COMPONENT MALFUNCTION AND CODED TO MEDDRA PT: DEVICE MALFUNCTION. THE PEN WAS RECEIVED INTACT WITH NO VISIBLE DAMAGE TO THE PEN ASSEMBLY. THE SEPTUM APPEARED NORMAL WITH ONLY 1 VISIBLE NEEDLE PUNCTURE. THE PLUNGER WAS NOT VISIBLE IN THE CARTRIDGE WINDOW. THE PEN DID NOT DIAL TO 80. THE DIALING MECHANISM ONLY TURNED UNTIL THE TIP OF THE FIRST ARROW WAS VISIBLE. NO CLICKS WERE HEARD. A PEN FUNCTIONALITY TEST COULD NOT BE CONDUCTED. A TINY UNREPORTED AIR BUBBLE MUCH SMALLER THAN THE ZERO IN THE DOSE WINDOW WAS VISIBLE. THERE WAS NO VISIBLE DEBRIS ON THE PEN OR ON THE ENLARGED PICTURES OF THE DIALING MECHANISM. THE PEN WAS SENT TO YPSOMED AG ON (B)(6) 2021 FOR FURTHER INVESTIGATION AND VETTER PHARMA WAS NOTIFIED ON (B)(6) 2021. ACCORDING TO VETTER, THE LOT NUMBER OF THE PEN IS VALID (LOT: RT04102, EXP: 04/2023). THE TYMLOS PEN LOT# RT04102 WAS APPROVED FOR RELEASE IN OCT-2020 (QUANTITY OF (B)(4) UNITS WERE RELEASED FOR DISTRIBUTION). ZERO (0) PENS REMAIN IN INVENTORY AT RADIUS' THIRD PARTY LOGISTICS PROVIDER - ICS BROOKS, KY. THE YPSOMED DOSING MECHANISM PEN COMPONENT WAS SOURCED FROM TWO DIFFERENT BATCHES 4118753 (VETTER LOT 556184) AND 4120577 (VETTER LOT 571685). ACCORDING TO RADIUS-QA, NO CONFIRMED PRODUCT COMPLAINTS INVOLVING "PRODUCT DIFFICULT TO USE/DIFFICULT TO DELIVER A DOSE" OR "EMPTY OR SHORTFILLED CARTRIDGE" HAVE BEEN RECEIVED FOR LOT # RT04102 TO DATE. A PRELIMINARY REPORT WAS RECEIVED FROM YPSOMED ON (B)(6) 2021. A CT SCAN OF THE PEN WAS CONDUCTED AND SHOWED THAT THE DOSE WHEEL WAS IN THE LOCKED, STOP LAST DOSE POSITION WHICH WOULD SUGGEST THAT THE TOOTHED WHEEL ON THE DOSE BUTTON WAS NOT IN CORRECT RADIAL POSITION RELATIVE TO STOP WHEEL. SINCE THERE WAS MINIMAL OBSERVABLE DAMAGE TO THE PEN, PATIENT MANIPULATION WAS IDENTIFIED AS AN UNLIKELY ROOT CAUSE FOR THE MISALIGNMENT. THE PROBABLE ROOT CAUSE FOR THE MISALIGNMENT WAS IDENTIFIED AS WORN GUIDE PINS WHICH FIX THE STOP WHEEL DURING ASSEMBLY. YPSOMED HAS REPLACED THE TACTILE SENSORS WITH OPTICAL SENSORS DURING THE ASSEMBLY PROCESS. AS OF 30JUN2021, A RISK ASSESSMENT INVESTIGATION IS CURRENTLY ONGOING. FOLLOW-UP INFORMATION RECEIVED ON 09JUL2021: A SECOND REPORT WAS RECEIVED FROM VETTER, THE DRUG PRODUCT CARTRIDGE MANUFACTURER. VETTER REVIEWED THE ASSOCIATED PROCESS STEPS INCLUDING INCOMING INSPECTION OF THE DOSING MECHANISMS, PEN ASSEMBLY, AND FINAL PACKAGING. NO IRREGULARITIES OCCURRED AT THESE STEPS. THE IPC CHECKS AND QC TESTING MET THE REQUIREMENTS. RECORDS WERE REVIEWED FOR RELATED DEVIATIONS, EXCEPTIONS, AND FURTHER COMPLAINTS FOR BATCH RT041 (PEN LOT) AND RT04102 (PACKAGING LOT). NO EXCEPTIONS AND FURTHER COMPLAINTS WERE IDENTIFIED. RADIUS COMPLETED A TRENDING ASSESSMENT OF BATCH RT041 AND DID NOT IDENTIFY ANY ATYPICAL TRENDS.
THIS MALFUNCTION REPORT HAS BEEN PREPARED FOR A PRODUCT COMPLAINT ((B)(4)). ON 07MAY2021, THE PATIENT INITIALLY REPORTED TO RADIUS THAT SHE WAS UNABLE TO PRIME HER PEN (LOT # RT04102). THE PATIENT DID NOT REPORT ANY ADVERSE EXPERIENCE. ON 09JUN2021, DURING INSPECTION OF THE RETURNED SAMPLE, RADIUS-QA OBSERVED AN ISSUE WITH THE DOSING MECHANISM. THE COMPLAINT WAS UPDATED AS A DEVICE COMPONENT MALFUNCTION AND CODED TO MEDDRA PT: DEVICE MALFUNCTION. THE PEN WAS RECEIVED INTACT WITH NO VISIBLE DAMAGE TO THE PEN ASSEMBLY. THE SEPTUM APPEARED NORMAL WITH ONLY 1 VISIBLE NEEDLE PUNCTURE. THE PLUNGER WAS NOT VISIBLE IN THE CARTRIDGE WINDOW. THE PEN DID NOT DIAL TO 80. THE DIALING MECHANISM ONLY TURNED UNTIL THE TIP OF THE FIRST ARROW WAS VISIBLE. NO CLICKS WERE HEARD. A PEN FUNCTIONALITY TEST COULD NOT BE CONDUCTED. A TINY UNREPORTED AIR BUBBLE MUCH SMALLER THAN THE ZERO IN THE DOSE WINDOW WAS VISIBLE. THERE WAS NO VISIBLE DEBRIS ON THE PEN OR ON THE ENLARGED PICTURES OF THE DIALING MECHANISM. THE PEN WAS SENT TO YPSOMED AG ON 09JUN2021 FOR FURTHER INVESTIGATION AND VETTER PHARMA WAS NOTIFIED ON 09JUN2021. ACCORDING TO VETTER, THE LOT NUMBER OF THE PEN IS VALID (LOT: RT04102, EXP: 04/2023). THE TYMLOS PEN LOT# RT04102 WAS APPROVED FOR RELEASE IN OCT-2020 (QUANTITY OF 20,306 UNITS WERE RELEASED FOR DISTRIBUTION). ZERO (0) PENS REMAIN IN INVENTORY AT RADIUS' THIRD PARTY LOGISTICS PROVIDER - ICS BROOKS, KY. THE YPSOMED DOSING MECHANISM PEN COMPONENT WAS SOURCED FROM TWO DIFFERENT BATCHES 4118753 (VETTER LOT 556184) AND 4120577 (VETTER LOT 571685). ACCORDING TO RADIUS-QA, NO CONFIRMED PRODUCT COMPLAINTS INVOLVING "PRODUCT DIFFICULT TO USE/DIFFICULT TO DELIVER A DOSE" OR "EMPTY OR SHORTFILLED CARTRIDGE" HAVE BEEN RECEIVED FOR LOT # RT04102 TO DATE. A PRELIMINARY REPORT WAS RECEIVED FROM YPSOMED ON 18JUN2021. A CT SCAN OF THE PEN WAS CONDUCTED AND SHOWED THAT THE DOSE WHEEL WAS IN THE LOCKED, STOP LAST DOSE POSITION WHICH WOULD SUGGEST THAT THE TOOTHED WHEEL ON THE DOSE BUTTON WAS NOT IN CORRECT RADIAL POSITION RELATIVE TO STOP WHEEL. SINCE THERE WAS MINIMAL OBSERVABLE DAMAGE TO THE PEN, PATIENT MANIPULATION WAS IDENTIFIED AS AN UNLIKELY ROOT CAUSE FOR THE MISALIGNMENT. THE PROBABLE ROOT CAUSE FOR THE MISALIGNMENT WAS IDENTIFIED AS WORN GUIDE PINS WHICH FIX THE STOP WHEEL DURING ASSEMBLY. YPSOMED HAS REPLACED THE TACTILE SENSORS WITH OPTICAL SENSORS DURING THE ASSEMBLY PROCESS. AS OF 30JUN2021, A RISK ASSESSMENT INVESTIGATION IS CURRENTLY ONGOING. FOLLOW-UP # 1 (BASED ON INFORMATION RECEIVED ON 09JUL2021): A SECOND REPORT WAS RECEIVED FROM VETTER, THE DRUG PRODUCT CARTRIDGE MANUFACTURER. VETTER REVIEWED THE ASSOCIATED PROCESS STEPS INCLUDING INCOMING INSPECTION OF THE DOSING MECHANISMS, PEN ASSEMBLY, AND FINAL PACKAGING. NO IRREGULARITIES OCCURRED AT THESE STEPS. THE IPC CHECKS AND QC TESTING MET THE REQUIREMENTS. RECORDS WERE REVIEWED FOR RELATED DEVIATIONS, EXCEPTIONS, AND FURTHER COMPLAINTS FOR BATCH RT041 (PEN LOT) AND RT04102 (PACKAGING LOT). NO EXCEPTIONS AND FURTHER COMPLAINTS WERE IDENTIFIED. RADIUS COMPLETED A TRENDING ASSESSMENT OF BATCH RT041 AND DID NOT IDENTIFY ANY ATYPICAL TRENDS. FOLLOW-UP # 2 (BASED ON INFORMATION RECEIVED ON 13 AUG 2021): YPSOMED'S FINAL INVESTIGATION REPORT RE-CONFIRMED THE ROOT CAUSE AND CORRECTIVE ACTION THAT WERE DEFINED IN THE REPORT PROVIDED ON 18JUN2021. THE IN-PROCESS REJECTION RATES FOR THE TWO DOSING MECHANISM BATCHES WERE WITHIN TYPICAL RANGES. NO RELEVANT MAINTENANCE RECORDS WERE MADE DURING THE ASSEMBLY OF THE POTENTIALLY AFFECTED BATCHES. THE PROBABILITY OF OCCURRENCE FOR THE LIKELY CAUSE IS CONSIDERED VERY LOW, SINCE THE DAMAGE TO THE GUIDE PINS WOULD HAVE TO OCCUR AFTER THE INSPECTION OF THE PINS AND BEFORE THE ASSEMBLY OF THE DOSE SLEEVE. LASTLY, IT IS UNLIKELY THAT ADDITIONAL DOSING MECHANISMS WERE AFFECTED BY DAMAGE TO THE GUIDE PINS. THE PROBABLE ROOT CAUSE FOR THE MISALIGNMENT WAS IDENTIFIED AS WORN GUIDE PINS WHICH FIX THE STOP WHEEL DURING ASSEMBLY. YPSOMED HAS REPLACED THE TACTILE SENSORS WITH OPTICAL SENSORS DURING THE ASSEMBLY PROCESS WHICH WILL ALLEVIATE THIS ISSUE GOING FORWARD.
THIS MALFUNCTION REPORT HAS BEEN PREPARED FOR A PRODUCT COMPLAINT (B)(4). ON (B)(6) 2021, THE PATIENT INITIALLY REPORTED TO RADIUS THAT SHE WAS UNABLE TO PRIME HER PEN (LOT # RT04102). THE PATIENT DID NOT REPORT ANY ADVERSE EXPERIENCE. ON (B)(6) 2021, DURING INSPECTION OF THE RETURNED SAMPLE, RADIUS-QA OBSERVED AN ISSUE WITH THE DOSING MECHANISM. THE COMPLAINT WAS UPDATED AS A DEVICE COMPONENT MALFUNCTION AND CODED TO MEDDRA PT: DEVICE MALFUNCTION. THE PEN WAS RECEIVED INTACT WITH NO VISIBLE DAMAGE TO THE PEN ASSEMBLY. THE SEPTUM APPEARED NORMAL WITH ONLY 1 VISIBLE NEEDLE PUNCTURE. THE PLUNGER WAS NOT VISIBLE IN THE CARTRIDGE WINDOW. THE PEN DID NOT DIAL TO 80. THE DIALING MECHANISM ONLY TURNED UNTIL THE TIP OF THE FIRST ARROW WAS VISIBLE. NO CLICKS WERE HEARD. A PEN FUNCTIONALITY TEST COULD NOT BE CONDUCTED. A TINY UNREPORTED AIR BUBBLE MUCH SMALLER THAN THE ZERO IN THE DOSE WINDOW WAS VISIBLE. THERE WAS NO VISIBLE DEBRIS ON THE PEN OR ON THE ENLARGED PICTURES OF THE DIALING MECHANISM. THE PEN WAS SENT TO YPSOMED AG ON (B)(6) 2021 FOR FURTHER INVESTIGATION AND VETTER PHARMA WAS NOTIFIED ON (B)(6) 2021. ACCORDING TO VETTER, THE LOT NUMBER OF THE PEN IS VALID (LOT: RT04102, EXP: 04/2023). THE TYMLOS PEN LOT# RT04102 WAS APPROVED FOR RELEASE IN OCT-2020 (QUANTITY OF 20,306 UNITS WERE RELEASED FOR DISTRIBUTION). ZERO (0) PENS REMAIN IN INVENTORY AT RADIUS' THIRD PARTY LOGISTICS PROVIDER - (B)(4), (B)(6). THE YPSOMED DOSING MECHANISM PEN COMPONENT WAS SOURCED FROM TWO DIFFERENT BATCHES 4118753 (VETTER LOT 556184) AND 4120577 (VETTER LOT 571685). ACCORDING TO RADIUS-QA, NO CONFIRMED PRODUCT COMPLAINTS INVOLVING "PRODUCT DIFFICULT TO USE/DIFFICULT TO DELIVER A DOSE" OR "EMPTY OR SHORTFILLED CARTRIDGE" HAVE BEEN RECEIVED FOR LOT # RT04102 TO DATE. A PRELIMINARY REPORT WAS RECEIVED FROM YPSOMED ON (B)(6) 2021. A CT SCAN OF THE PEN WAS CONDUCTED AND SHOWED THAT THE DOSE WHEEL WAS IN THE LOCKED, STOP LAST DOSE POSITION WHICH WOULD SUGGEST THAT THE TOOTHED WHEEL ON THE DOSE BUTTON WAS NOT IN CORRECT RADIAL POSITION RELATIVE TO STOP WHEEL. SINCE THERE WAS MINIMAL OBSERVABLE DAMAGE TO THE PEN, PATIENT MANIPULATION WAS IDENTIFIED AS AN UNLIKELY ROOT CAUSE FOR THE MISALIGNMENT. THE PROBABLE ROOT CAUSE FOR THE MISALIGNMENT WAS IDENTIFIED AS WORN GUIDE PINS WHICH FIX THE STOP WHEEL DURING ASSEMBLY. YPSOMED HAS REPLACED THE TACTILE SENSORS WITH OPTICAL SENSORS DURING THE ASSEMBLY PROCESS. AS OF (B)(6) 2021, A RISK ASSESSMENT INVESTIGATION IS CURRENTLY ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1036962 | TYMLOS SINGLE PATIENT-USE PREFILLED PEN | TYMLOS PEN | NSC | RADIUS HEALTH, INC. | RT04102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |