FDA Adverse Event
Injury
Summary report: N
MINIMED INFUSION PUMP
MDR report key: 20212368
·
Received September 12, 2024
Report
- Report Number
- MW5159561
- Event Type
- Injury
- Date Received
- September 12, 2024
- Date of Event
- September 10, 2024
- Report Date
- September 12, 2024
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Description of Event or Problem · 0
CALLER STATED THAT HE RECEIVED A TEXT FROM MEDTRONIC ADVISING HIM TO REPORT TO FDA THAT THE BATTERY CAP OF HIS MINIMED INFUSION PUMP IS FAULTY.
Description of Event or Problem · 0
ADD'L INFO RECEIVED FOR REPORT MW5159561 ON 10/02/2024 TO CHANGE PROCODE TO OZP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1129832 | MINIMED INFUSION PUMP | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC MINIMED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |