FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4242734
·
Received November 11, 2014
Report
- Report Number
- 2032227-2014-50210
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- September 13, 2014
- Report Date
- October 13, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD PIECES BREAKING OFF OF THE RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 299 MG/DL. STANDARD TROUBLESHOOTING WAS PERFORMED, BUT UNABLE TO BE COMPLETED BECAUSE THE CUSTOMER'S PARENTS DID NOT WANT TO CHANGE OUT HER INFUSION SET. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725031 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-551NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |