FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 3933287
·
Received July 14, 2014
Report
- Report Number
- 3004209178-2014-87040
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 15, 2014
- Report Date
- June 15, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
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'S HUSBAND REPORTED THAT THE INSULIN PUMP WAS MALFUNCTIONING. CUSTOMER REPORTED A CONSTANT TONE DURING BASAL. CUSTOMER ALSO STATED THAT THE BUTTONS ON THE INSULIN PUMP ARE UNRESPONSIVE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 157 MG/DL. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409797 | 530G INSULIN PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |