FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4123021
·
Received September 26, 2014
Report
- Report Number
- 2032227-2014-29536
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 28, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP PASSED DISPLACEMENT AND SELF TESTS. THE UNIT HAD MINOR SCRATCHES TO LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND STAINED ADDRESS OR SERIAL NUMBER LABEL.
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. 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. (B)(4).
Description of Event or Problem · 1
CUSTOMER CALLED BECAUSE SHE RECEIVED A NOTICE ABOUT A VOLUNTARY RECALL REGARDING THE SCROLL WRAP FEATURE ON HER INSULIN PUMP. THE RECALL RELATES TO ACCIDENTAL BUTTON PUSHING. CUSTOMER DECIDED TO HAVE HER DEVICE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600735 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC MINIMED | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |