FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4103394
·
Received September 19, 2014
Report
- Report Number
- 2032227-2014-25273
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- P120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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.
Description of Event or Problem · 1
CUSTOMER REPORTED A BUTTON ERROR ALARM ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 112 MG/DL. SHE DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THIS ALARM. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584359 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC MINIMED | MMT-751NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |