FDA Adverse Event
Injury
Summary report: N
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
MDR report key: 7923167
·
Received October 1, 2018
Report
- Report Number
- 2032227-2018-35575
- Event Type
- Injury
- Date Received
- October 1, 2018
- Date of Event
- August 28, 2018
- Report Date
- October 1, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 00763000090203
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S INCIDENT BLOOD GLUCOSE LEVEL WAS 588 MG/DL. TROUBLESHOOTING WAS NOT PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. OZO MMT-7020A SNSR; FRN-UNK-RSVR; UNOMED SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 765617 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG2N0BL | 00763000090203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other | OZO MMT-7020A SNSRFRN-UNK-RSVRUNOMED SET |