FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4250939 · Received November 14, 2014

Report

Report Number: 2032227-2014-52580
Event Type: Malfunction
Date Received: November 14, 2014
Date of Event: October 16, 2014
Report Date: October 18, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: PATIENT

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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.(B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE IN THE 300 MG/DL TO 499 MG/DL RANGE FOR A COUPLE OF DAYS. AT THE TIME OF REPORTING THIS, THE CUSTOMER'S BLOOD GLUCOSE WAS 331 MG/DL AND SHE TREATED WITH A PEN. TROUBLESHOOTING WAS PERFORMED. A SMALL BUBBLE WAS FOUND IN THE TUBING. INSULIN EXITED THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. IN THE ALARM HISTORY, LOW RESERVOIR AND WEAK BATTERY ALERTS WERE FOUND. BOLUS HISTORY WAS ACCURATE. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. WHEN THE CUSTOMER REMOVED THE INFUSION SET FROM HER BODY, THE NEEDLE WAS NOT BENT. THE CUSTOMER WAS ADVISED TO SPEAK WITH HER HEALTHCARE PROVIDER ABOUT THE SETTINGS AS SHE WAS NOT SURE IF HER BASAL RATE OR BOLUS WIZARD SETTINGS WERE CORRECT. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
738010	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523LNAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR