FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
MDR report key: 8864690
·
Received August 6, 2019
Report
- Report Number
- 2032227-2019-42097
- Event Type
- Malfunction
- Date Received
- August 6, 2019
- Date of Event
- July 25, 2019
- Report Date
- August 6, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 00763000190460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF INSULIN PUMP WAS NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT DISPLAY WAS FROZEN AND CLOCK DID NOT ADVANCED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658156 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG3G7VA | 00763000190460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |