FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
MDR report key: 8308225
·
Received February 5, 2019
Report
- Report Number
- 3004209178-2019-51092
- Event Type
- Malfunction
- Date Received
- February 5, 2019
- Date of Event
- October 30, 2018
- Report Date
- February 4, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 00763000090203
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP PASSED SELF TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH THE AUDIO ALERT FUNCTIONING PROPERLY. NO AUDIO ALERT ANOMALY NOTED. PUMP ERROR HARDWARE LOW LEVEL FAILURE ALARM (VARIABLE 3) CONFIRMED IN THE PUMP HISTORY DUE TO BROKEN PIN 6 TRACE (SDA) ON U1 KEYPAD ASSEMBLY.
Description of Event or Problem · 1
THE CUSTOMER WAS ASSISTED FOR VIBRATE MODE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101616 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG2E2AZ | 00763000090203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |