FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4103515 · Received September 19, 2014

Report

Report Number: 2032227-2014-26503
Event Type: Malfunction
Date Received: September 19, 2014
Date of Event: August 21, 2014
Report Date: August 21, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

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

IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING MOTOR ERROR. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 121 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
584256	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-554LCMS

Patients

Seq	Age	Sex	Outcome	Treatment
1