FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3942400 · Received July 17, 2014

Report

Report Number: 3004209178-2014-87563
Event Type: Malfunction
Date Received: July 17, 2014
Date of Event: June 17, 2014
Report Date: June 17, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI
Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE LIP.

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.

Description of Event or Problem · 1

CUSTOMER'S MOTHER CALLED STATING THE ESC AND ACT BUTTON ON HER DAUGHTER'S INSULIN PUMP ARE NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 111 MG/DL. CUSTOMER ALSO SAID THE UP AND DOWN BUTTONS HAD INTERMITTENT RESPONSES. THE ESC AND ACT BUTTONS ARE WORSE THAN THE OTHER ONES. CUSTOMER DID NOT HAVE HER WAISTBAND, SO SHE HAD ATTACHED THE DEVICE TO HER BRA. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
419803	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAP

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR