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