FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4233115
·
Received November 6, 2014
Report
- Report Number
- 2032227-2014-48688
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 9, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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. 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.(B)(4)
Additional Manufacturer Narrative · 1
THE INSULIN PUMP RECEIVED WITH MISSING SEGMENTS DUE TO CRACKED AND BLEEDING LCD GLASS AND MINOR SCRATCHED LCD WINDOW.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LCD SCREEN OF THE CUSTOMER'S INSULIN PUMP WAS DAMAGED AND THERE WERE MISSING SEGMENTS, AFTER THE PUMP FELL OUT OF HIS POCKET. THE CUSTOMER ALSO STATED THERE WAS A SCRATCH ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715171 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |