FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4112159
·
Received September 23, 2014
Report
- Report Number
- 2032227-2014-27559
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 25, 2014
- Report Date
- August 25, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.
Additional Manufacturer Narrative · 1
(B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 THAT THEY WERE ATTEMPTING TO CLEAR A LOW RESERVOIR ALERT ON THE INSULIN PUMP AND THE BUTTONS WERE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 86 MG/DL. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592344 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC MINIMED | MMT-751NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |