FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3882465 · Received June 18, 2014

Report

Report Number: 3004209178-2014-85924
Event Type: Injury
Date Received: June 18, 2014
Date of Event: May 30, 2014
Report Date: July 1, 2016
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX
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

THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

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 HAVING LOW BLOOD GLUCOSE OF 31MG/DL. SHE REPORTED THAT SHE RECEIVED EMERGENCY MEDICAL ATTENTION AFTER SUSPENDING THE INSULIN PUMP USE AND LOW BLOOD GLUCOSE PERSISTING. AFTER BEING TREATED BY THE PARAMEDICS, BLOOD GLUCOSE LEVEL INCREASED TO 400MG/DL. TROUBLESHOOTING WAS PERFORMED AND NO MALFUNCTIONING OF THE DEVICE NOTED. CURRENT BLOOD GLUCOSE IS 279MG/DL. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356937	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAB

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention