FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554CAL

MDR report key: 8864570 · Received August 6, 2019

Report

Report Number: 2032227-2019-42078
Event Type: Malfunction
Date Received: August 6, 2019
Date of Event: July 23, 2019
Report Date: August 6, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
UDI-DI: 00643169519022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT HE INSULIN PUMP HAD COMPROMISED FORCED SENSOR SYSTEM ERROR AND INSULIN SQUIRTED OUT DURING MANUAL PRIME. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS DISCONNECTED DURING PRIME. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NOT DAMAGED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
659927	PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554CAL	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-554CAL	B1554CALJ	00643169519022

Patients

Seq	Age	Sex	Outcome	Treatment
1