FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
MDR report key: 8648500
·
Received May 29, 2019
Report
- Report Number
- 2032227-2019-08160
- Event Type
- Malfunction
- Date Received
- May 29, 2019
- Date of Event
- March 25, 2019
- Report Date
- May 28, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 00643169939219
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PUMP ERROR ALARM NOTED DURING TESTING, HOWEVER NOTED IN TRACE DOWNLOAD ANALYSIS DUE TO MOISTURE DAMAGE. UNIT PASSED OCCLUSION TEST, FORCE SENSOR TEST, BASIC OCCLUSION TEST, PRIME/SEATING TEST, REWIND TEST AND DISPLACEMENT TEST. DURING VISUAL INSPECTION, FOUND MOTOR, FORCE SENSOR AND ELECTRONIC STACK MOISTURE DAMAGE.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD PUMP ERROR. CUSTOMER'S BLOOD GLUCOSE VALUE AT THE TIME OF INCIDENT WAS 160 MG/DL. CUSTOMER STATED INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 443087 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG1XMD0 | 00643169939219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |