FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAH PRDGM INS PK
MDR report key: 1811972
·
Received August 17, 2010
Report
- Report Number
- 3004209178-2010-82499
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 26, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY, AND THE CUSTOMER ENDED UP IN THE HOSPITAL TWO WEEKS AGO DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 585 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND ALARM HISTORY WERE CORRECT. THE INFUSION SET WAS CHANGED AND THE CUSTOMER DID NOT WANT TO DISCONNECT AGAIN AND RAN INSULIN THRU THE DEVICE TO PERFORM THE HIGH PRESSURE TEST. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAH PRDGM INS PK | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization |