FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
MDR report key: 1931033
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-83528
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 24, 2010
- Report Date
- November 24, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
THE CUSTOMER CALLED FROM THE EMERGENCY ROOM TO REPORT HAVING LOW BLOOD GLUCOSE OF 90MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL DROPPED DURING THE NIGHT, AND SHE WENT TO THE HOSPITAL IN CASE HER BLOOD GLUCOSE DROPPED LOW AGAIN. THE PROGRAMMED SETTINGS WERE CORRECT. THE CUSTOMER STATED THAT RECENTLY HER BASAL RATE WAS LOWERED. THE CUSTOMER ALSO STATED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE FOR THE PAST FIVE DAYS. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAL PRDGM INS V2.2 CL EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization |