FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
MDR report key: 1843451
·
Received September 21, 2010
Report
- Report Number
- 3004209178-2010-82872
- Event Type
- Injury
- Date Received
- September 21, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK 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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE DURING THE WEEKEND. THE MOTHER STATED THAT THE PARAMEDICS WERE CALLED. THE MOTHER ALSO STATED THAT THE CUSTOMER'S DOCTOR HAD CHANGED THE BASALS TO A HIGHER AMOUNT. THE PARAMEDICS TREATED THE CUSTOMER'S BLOOD GLUCOSE WITH GLUCACON TABLETS. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Required Intervention |