FDA Adverse Event
Injury
Summary report: N
BELT CLIP
MDR report key: 4183136
·
Received October 17, 2014
Report
- Report Number
- 2032227-2014-40146
- Event Type
- Injury
- Date Received
- October 17, 2014
- Date of Event
- August 29, 2014
- Report Date
- September 19, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 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.
Description of Event or Problem · 1
CUSTOMER REPORTED LOW BLOOD GLUCOSE OF 43 MG/DL; CUSTOMER DRANK ORANGE JUICE AND ATE A PEANUT BUTTER AND JELLY SANDWICH. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660578 | BELT CLIP | INSULIN INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-642 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |