FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4142054
·
Received October 4, 2014
Report
- Report Number
- 2032227-2014-33328
- Event Type
- Malfunction
- Date Received
- October 4, 2014
- Date of Event
- July 26, 2014
- Report Date
- September 5, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 WAS RECEIVED MISSING SEGMENTS ON LCD BOARD DUE TO CRACKED ZEBRA CONNECTOR AT LCD BOARD. THE INSULIN PUMP PASSED DISPLACEMENT, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TESTS. NO COSMETIC DAMAGE NOTED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT WHEN ATTEMPTING A BOLUS DELIVERY SHE NOTICED A PARTIAL LCD SCREEN AND A LINE GOING THROUGH SCREEN. CUSTOMER'S BLOOD GLUCOSE WAS 367 MG/DL. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621703 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |