FDA Adverse Event
Injury
Summary report: N
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
MDR report key: 7825542
·
Received August 28, 2018
Report
- Report Number
- 2032227-2018-19980
- Event Type
- Injury
- Date Received
- August 28, 2018
- Date of Event
- August 7, 2018
- Report Date
- August 28, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 00763000090203
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 410MG/DL. CUSTOMER EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL WAS 280,336,410MG/DL. CUSTOMER STATED THAT THEY HAD ISSUE WITH SENSOR. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. CONCOMITANT MEDICAL PRODUCTS: OZO-MMT-7020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666484 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG2KUMG | 00763000090203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |