FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3882470 · Received June 18, 2014

Report

Report Number: 3004209178-2014-85941
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: June 3, 2014
Report Date: June 3, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST AND A33 ALARM DURING THE PIRME/A33 TEST AT 4.0 LBS DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO A33 AND MOTOR ERROR ALARM. CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, SCRATCHED KEYPAD OVERLAY AND SCRATCHED CASE AND CRACKED BATTERY TUBE THREADS NOTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ALARMS. CUSTOMER STATED THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. DURING TROUBLESHOOTING THE CUSTOMER STATED THE DRIVE SUPPORT CAP IS STICKING OUT. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. THE BLOOD GLUCOSE READING WAS 72MG/DL. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357563	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR