N
Patient 0
THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED.
MAUDE MDR 25341028
- MDR report key
- 25341028
- Report number
- 2954323-2026-101936
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-04-16
- Date received
- 2026-05-31
- Adverse event
- 1
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- PATRICIA REIS CASTRO
- Address
- 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US
- Phone
- 415-415-4157
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 193110 | FREESTYLE LIBRE 3 PLUS | CONTINUOUS GLUCOSE MONITORING SYSTEM | ABBOTT DIABETES CARE INC | QBJ | 78768-01 | N | N | |||||
| 288069 | FREESTYLE LIBRE 3 PLUS | CONTINUOUS GLUCOSE MONITORING SYSTEM | ABBOTT DIABETES CARE INC | QBJ | 78768-01 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-05-31 | 0 | R |
Event Narratives#
D
Patient 0
A BENT INSERTER NEEDLE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. IT WAS REPORTED THAT WHILE ATTEMPTING TO APPLY THE ADC DEVICE, IT WAS DISCOVERED THAT THE NEEDLE WAS BENT. DURING THE APPLICATION, A SMALL HOLE PUNCTURED THE CUSTOMER'S ARM AND A "TOUCH OF BLOOD" WAS VISIBLE. THE CUSTOMER'S SPOUSE THOUGHT THE NEEDLE WAS LEFT IN THE CUSTOMER'S SKIN THEREFORE, A TWEEZER WAS USED AND A "SMALL PIECE OF BLACK STRING" WAS PULLED OUT OF THE CUSTOMER'S ARM FOR TREATMENT INSTEAD OF A NEEDLE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.