FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 3930539
·
Received July 12, 2014
Report
- Report Number
- 3004209178-2014-86795
- Event Type
- Malfunction
- Date Received
- July 12, 2014
- Date of Event
- June 8, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD MISSING SEGMENTS DUE TO CRACKED ZEBRA CONNECTOR ON LCD BOARD. NO COSMETIC DAMAGE NOTED.
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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS PUMP HAD A PARTIAL DISPLAY. THE BLOOD GLUCOSE READING WAS 145 MG/DL. TROUBLESHOOTING WAS PERFORMED. A NEW BATTERY DID NOT HELP RESOLVE THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408798 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |