FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
MDR report key: 1844837
·
Received September 22, 2010
Report
- Report Number
- 3004209178-2010-82890
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- October 28, 2008
- Report Date
- September 9, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 THE ATTORNEY ALLEGES THAT THE CUSTOMER FAILED TO RECEIVE THE CORRECT DOSAGE OF INSULIN TO MANAGE HIS DIABETIC CONDITION, AND THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER ALLEGED SUFFERING FURTHER INJURY, WHICH REQUIRED MEDICAL PROCEDURES AND A SECOND HOSPITALIZATION AS A RESULT OF THE INSULIN PUMP FAILURE. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |