FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 3953999 · Received July 23, 2014

Report

Report Number: 3004209178-2014-88123
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: June 24, 2014
Report Date: June 24, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ
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.

Additional Manufacturer Narrative · 1

THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A PROTRUDED AND LOOSE DRIVE SUPPORT DISK. NO ALARM WAS NOTED FOR THE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A BROKEN RESERVOIR TUBE LIP.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP SENT AN ERROR ALARM. THE CUSTOMER NOTICED INSULIN SQUIRTING OUT WHEN THEY WANTED TO CHANGE THE INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE WAS 148 MG/DL. THE ALARM OCCURRED DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS STICKING OUT. THE CUSTOMER DID NOT PRESS THE CAP WHILE CONNECTED TO THE DEVICE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. THE CUSTOMER DECLINED SENDING THE INSULIN PUMP BACK FOR FAILURE ANALYSIS. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
431375	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR