FDA Adverse Event
Injury
Summary report: N
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
MDR report key: 7360009
·
Received March 21, 2018
Report
- Report Number
- 3004209178-2018-58667
- Event Type
- Injury
- Date Received
- March 21, 2018
- Date of Event
- February 22, 2018
- Report Date
- March 21, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 00643169939219
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON UNKNOWN DATE WITH BLOOD GLUCOSE OF 403 AND ABOVE. PATIENT'S OTHER BLOOD GLUCOSE VALUES WERE 214 AND 400 MG/DL. PATIENT'S SENSOR GLUCOSE VALUES WERE 240, 247 AND 395 MG/DL. INSULIN DELIVERY WAS NOT SUSPENDED DUE TO SENSOR GLUCOSE VALUES. CUSTOMER DECLINED TO TROUBLESHOOT FOR THEIR BLOOD GLUCOSE LEVELS. THE DEVICES ARE NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199621 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG28BQH | 00643169939219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| O |