FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4061205
·
Received September 4, 2014
Report
- Report Number
- 2032227-2014-16859
- Event Type
- Malfunction
- Date Received
- September 4, 2014
- Date of Event
- August 3, 2014
- Report Date
- August 5, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
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
CUSTOMER REPORTED ISSUES WITH THE AIR BUBBLES NEAR THE RESERVOIR. FURTHERMORE, THE CUSTOMER HAD HIGH BLOOD GLUCOSE AND THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE BLOOD GLUCOSE READING IS 350 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540776 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC MINIMED | MMT-551NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |