FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4871569 · Received June 26, 2015

Report

Report Number: 3004209178-2015-69086
Event Type: Malfunction
Date Received: June 26, 2015
Date of Event: June 8, 2015
Report Date: June 8, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

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. HOWEVER, THE PUMP HAD A CRACKED BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, AND CRACKS ON THE DISPLAY WINDOW.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER HAD AN OFF NO POWER ALARM ON THE INSULIN PUMP. CUSTOMER USED A BRAND NEW ENERGIZER AAA BATTERY AND HAD A LOW BATTERY ALERT IN THE ALARM HISTORY. THE PUMP WAS NOT BUMPED OR DROPPED. CUSTOMER'S BATTERY CAP WAS OKAY. THE INSULIN PUMP WILL BE REPLACED. CUSTOMER WAS ASKED VERBALLY AND IN WRITTEN FORM TO RETURN THE PUMP FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414499	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722WWP

Patients

Seq	Age	Sex	Outcome	Treatment
1