FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4132077
·
Received October 1, 2014
Report
- Report Number
- 2032227-2014-30944
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- August 31, 2014
- Report Date
- September 1, 2014
- Manufacturer
- MEDTRONIC MINIMED
- 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
(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.
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS A MOTOR ERROR ALARM. THE BLOOD GLUCOSE READING IS 240 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611332 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC MINIMED | MMT-751NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |