FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 6086574
·
Received November 8, 2016
Report
- Report Number
- 2032227-2016-40756
- Event Type
- Malfunction
- Date Received
- November 8, 2016
- Date of Event
- October 13, 2016
- Report Date
- October 13, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
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. (B)(4).
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED VIA THE INTERDEPARTMENTAL HELPLINE SOLUTIONS TRACKER OF A CUSTOMER'S EMAIL REGARDING EXCESSIVE NO DELIVERY ALARMS. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER INDICATED OF NEEDING ASSISTANCE WITH THE INFUSION SETS. TROUBLESHOOTING LEFT A MESSAGE FOR THE CUSTOMER TO CALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739057 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |