FDA Adverse Event
Malfunction
Summary report: N
NOVOPEN 3
MDR report key: 246240
·
Received October 25, 1999
Report
- Report Number
- 9681821-1999-00040
- Event Type
- Malfunction
- Date Received
- October 25, 1999
- Report Date
- October 21, 1999
- Manufacturer
- NOVO NORDISK A/S
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
REPORTABLE MALFUNCTION: (CN 200232): ON SEPT-30-99 NOVO NORDISK A/S REC'D A NOVOPEN 3 DEVICE FROM THE UNITED STATES WITH THE FOLLOWING COMPLAINT: "PISTON ROD IS STUCK IN THE EXTENDED POSITION." THERE WAS NO INDICATION OF AN ADVERSE EVENT. RESULT AND CONCLUSION OF MFR'S INVESTIGATION: ON OCT-1-99, NOVO NORDISK ESTABLISHED THAT THE COLLAR ON THE PISTON ROD NUT WAS BROKEN OFF. THE DEVICE WAS TESTED FOR DOSAGE ACCURACY AT DOSE SIZES 2, 5, 10 AND 20 IU (1 IU - 10 MG:. CONCLUSION - THE FAULT "COLLAR ON PISTON ROD NUT BROKEN OFF" WAS EVALUATED AS A REPORTABLE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVOPEN 3 | INSULIN INJECTION DEVICE | FMF | NOVO NORDISK A/S | NA | HW40058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |