FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3882461 · Received June 18, 2014

Report

Report Number: 3004209178-2014-85927
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: June 6, 2014
Report Date: June 6, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

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 COMPLAINED ABOUT HIS BLOOD GLUCOSE LEVELS NOT BEING STABLE RECENTLY. HE STATED THAT THE BLOOD GLUCOSE READINGS HAVE BEEN BETWEEN 200MG/DL AND 300 MG/DL . CURRENT BLOOD GLUCOSE IS 183MG/DL, HE IS WEARING THE INSULIN PUMP AND IN ADDITION TREATING WITH INSULIN MANUAL INJECTIONS. AFTER TREATING HIMSELF, HE STATED HE WAS EXPERIENCING LOW BLOOD GLUCOSE. CUSTOMER UNABLE TO MEASURE HIS BLOOD GLUCOSE LEVEL AT THE TIME AND JUST TREATED WITH FOOD INGESTION. DURING TROUBLESHOOT TESTING, IT WAS IDENTIFIED THAT THE INSULIN PUMP IS NOT PROVIDING NO DELIVERY ALARMS AS INTENDED. PRODUCT HAS BEEN REPLACED. NOTHING FURTHER TO REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357544	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	52 YR