FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 19939866
·
Received August 8, 2024
Report
- Report Number
- 3005798905-2024-03197
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- August 5, 2024
- Report Date
- August 8, 2024
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMI
- PMA / PMN Number
- K112789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RETAINED LOT SAMPLES FOR SYRINGE LOT 609702P WERE TESTED FOR CLOGGING. NO ABNORMALITIES WERE FOUND DURING TESTING.
Additional Manufacturer Narrative · 0
INITIAL TREND ANALYSIS FOR LOT 609702P WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 609702P. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Description of Event or Problem · 0
END USER REPORTS PN FROM LOT 609702P IS NOT DISPENSING ANY INSULIN FROM A LANTUS INSULIN PEN.
Description of Event or Problem · 0
END USER REPORTS PN FROM LOT 609702P IS NOT DISPENSING ANY INSULIN FROM A LANTUS INSULIN PEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2395266 | EASYTOUCH | PEN NEEDLE | FMI | FEEL TECH BIO CO., LTD. | 609702P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |