PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

Report

Report Number: 2032227-2014-52821
Event Type: Injury
Date Received: November 14, 2014
Date of Event: October 19, 2014
Report Date: October 19, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED BY HOSPITAL NURSE THAT CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 WITH BLOOD GLUCOSE OF 600 MG/DL. CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE. IT WAS UNCLEAR IF CUSTOMER WAS WEARING INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER WAS TREATED WITH INSULIN DRIP. IT WAS REPORTED THAT CUSTOMER RECEIVED A BATTERY OUT LIMIT AND WEAK SIGNAL. TROUBLESHOOTING WAS PERFORMED WITH CUSTOMER'S WIFE. DURING TROUBLESHOOTING, IT WAS FOUND THAT CUSTOMER HAD EXCESSIVE NO DELIVERY ALARMS AND EXCESSIVE UNDER DELIVERED BOLUS DUE TO NO DELIVERY. CUSTOMER'S WIFE WAS NOT COMFORTABLE IN DOING THE HIGH PRESSURE TEST WHILE AT THE HOSPITAL. CUSTOMER'S WIFE WAS ADVISED THAT INSULIN PUMP WAS FUNCTIONING FINE AND TO CHANGE INFUSION SET AND RESERVOIR AND TO CONFIRM SETTING WITH HEALTHCARE PROFESSIONAL. NO FURTHER INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
736443	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723LNAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Hospitalization