FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3911195 · Received July 2, 2014

Report

Report Number: 3004209178-2014-86375
Event Type: Injury
Date Received: July 2, 2014
Date of Event: June 3, 2014
Report Date: June 13, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA
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

THE CUSTOMER REPORTED THAT SHE WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 600 MG/DL AT THE TIME OF THE EMERGENCY ROOM VISIT AND 88 MG/DL AT THE TIME THE CUSTOMER REPORTED THE VISIT. THE CUSTOMER STATED THAT HER SYMPTOMS WERE KETONES AND THROWING UP. DURING TROUBLESHOOTING, THE TIME AND DATE WERE FOUND TO BE CORRECT ON THE INSULIN PUMP AS WELL AS THE BASAL RATES. A HIGH PRESSURE TEST WAS ALSO PERFORMED AND THE INSULIN PUMP PASSED. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
385902	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	49 YR		Hospitalization