FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3831146 · Received May 23, 2014

Report

Report Number: 3004209178-2014-84936
Event Type: Malfunction
Date Received: May 23, 2014
Date of Event: May 3, 2014
Report Date: May 3, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MT
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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Additional Manufacturer Narrative · 1

INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO VERY ALARM HISTORY DUE TO CORRUPTED HISTORY FILE. CRACKS TO THE CASE, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, A SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW NOTED.

Description of Event or Problem · 1

CUSTOMER CALLED REPORTING THAT HIS INSULIN PUMP ALARMED DURING THE REWIND PROCESS. CUSTOMER ALSO STATED THE INSULIN PUMP ALARMED BEFORE HE TOOK OUT THE BATTERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 70 MG/DL. CUSTOMER REPORTED SEEING INSULIN SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER REPORTED BEING STUCK IN A REWIND COMPLETE/BOLUS DELIVERY LOOP. AFTER CHECKING, CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308680	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	46 YR