FDA Adverse Event
Injury
Summary report: N
530G INSULIN PUMP
MDR report key: 4110574
·
Received September 23, 2014
Report
- Report Number
- 2032227-2014-27421
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- August 25, 2014
- Report Date
- August 25, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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 THAT SHE LOW BLOOD GLUCOSE. SHE ALSO STATED THAT HER LOW BLOOD GLUCOSE REQUIRED MEDICAL ATTENTION. HER EXACT BLOOD GLUCOSE WAS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591396 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC MINIMED | MMT-551NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |