FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3813030 · Received May 15, 2014

Report

Report Number: 3004209178-2014-84631
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 25, 2014
Report Date: April 25, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

INSULIN PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO A UNLOCKED KEYPAD CONNECTOR. NO FROZEN DISPLAY NOTED WHEN DEVICE WAS ANALYZED USING A TEST KEYPAD. A BROKEN RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW, MISSING END CAP STICKER, SCRATCHED RESERVOIR TUBE WINDOW, BROKEN BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS NOTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE BUTTONS ARE NOT RESPONDING. THE BATTERY WAS CHANGED AND HAD THE SAME RESULTS. THE BLOOD GLUCOSE LEVEL AT TIME OF CALL WAS 286MG/DL. INSTRUCTED THE CALLER TO REMOVED THE BATTERY FOR FIVE MINUTES AND TO INSERT A NEW BATTERY, BUT THE DISPLAY WAS FROZEN WITH NO ADVANCEMENT OF THE TIME. ADVISED THE CUSTOMER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291233	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR