FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 3984374 · Received August 6, 2014

Report

Report Number: 3004209178-2014-90515
Event Type: Malfunction
Date Received: August 6, 2014
Date of Event: July 6, 2014
Report Date: July 6, 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

THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE, RESERVOIR TUBE WINDOW, BROKEN RESERVOIR TUBE LIP AND MINOR SCRATCHED LCD WINDOW.

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.

Description of Event or Problem · 1

IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING BUTTON ERROR. CUSTOMER STATED THEY DID NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED, BUT MENTIONED IT MAY HAVE BEEN EXPOSED TO MOISTURE WHEN IT WAS PLACED NEXT TO A SINK. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 91 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
461447	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR