FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
MDR report key: 1902334
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-83342
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- September 21, 2010
- Report Date
- November 2, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THREE WEEKS AGO, THE INSULIN PUMP EMPTIED AN ENTIRE BOTTLE OF INSULIN INTO HIM. THE CUSTOMER STATED THAT HE HAS BEEN OFF THE PUMP FOR FIVE WEEKS. THE CUSTOMER STATED THERE WAS NOTHING TO INDICATE THAT THE INSULIN PUMP MALFUNCTIONED. THE CUSTOMER STATED THAT HE WAS HOSPITALIZED BECAUSE OF SEIZURES. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |