FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3974360 · Received August 1, 2014

Report

Report Number: 2032227-2014-05386
Event Type: Malfunction
Date Received: August 1, 2014
Date of Event: July 2, 2014
Report Date: July 2, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, NO DELIVERY ALARM AND MOTOR TESTS. NO MOTOR ERROR ALARM NOTED. THE DEVICE HAD MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

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 CALLED REPORTING A MOTOR ERROR ON HER INSULIN PUMP. THIS IS THE SECOND MOTOR ERROR TODAY. CUSTOMER'S BLOOD GLUCOSE IS 290 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. CUSTOMER DOES NOT USE THE SENSOR FEATURE. HE IS ABLE TO REWIND THE DEVICE. 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
450314	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-723LNAH

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR