FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4190914
·
Received October 21, 2014
Report
- Report Number
- 2032227-2014-40989
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 22, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
CUSTOMER REPORTED A MOTOR ERROR ALARM DURING THE END OF THE BOLUS. THE BLOOD GLUCOSE READING IS 98 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669989 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |