FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3970021 · Received July 31, 2014

Report

Report Number: 3004209178-2014-88387
Event Type: Malfunction
Date Received: July 31, 2014
Date of Event: July 1, 2014
Report Date: July 1, 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

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP QUIT WORKING, DID NOT DELIVER INSULIN, AND DID NOT ALARM TO NOTIFY THE CUSTOMER OF THE ABSENCE OF DELIVERY. THE BLOOD GLUCOSE READING WAS 250 MG/DL. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER HAD TAKEN HERSELF OFF THE INSULIN PUMP BECAUSE SHE DOES NOT TRUST IT AND HAS REVERTED BACK TO MANUAL INJECTIONS. HER DOCTOR ADVISED THAT THE INSULIN PUMP WAS NOT DELIVERY BASAL RATES AND RECOMMENDED REPLACEMENT OF THE DEVICE. THE CUSTOMER'S MOTHER REPORTED THAT THE DEVICE WENT 3 DAYS WITHOUT ADMINISTERING INSULIN WITHOUT ANY NOTIFICATION. SHE ALSO RECALLED THAT SHE HAD PERFORMED A TUBE CLAMP TEST AND THE DEVICE HAD NOT PASSED. ADVISED DISCONTINUATION AND REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
446584	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	16 YR