FDA Adverse Event
Injury
Summary report: N
530G INSULIN PUMP MMT-551LNAS
MDR report key: 7806915
·
Received August 22, 2018
Report
- Report Number
- 2032227-2018-16039
- Event Type
- Injury
- Date Received
- August 22, 2018
- Date of Event
- July 15, 2018
- Report Date
- August 22, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 00643169507739
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED. IT WAS ALSO MENTIONED THAT THE CUSTOMER REASON FOR HOSPITALIZATION WAS DUE TO BENT CANNULA. BLOOD GLUCOSE LEVEL WAS 1200 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN- RESERVOIR; OZO-SENSOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648723 | 530G INSULIN PUMP MMT-551LNAS | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551LNAS | A4551LNASJ | 00643169507739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization | FRN- RESERVOIROZO- SENSOR |