PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

Report

Report Number: 3004209178-2014-88134
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: June 24, 2014
Report Date: June 24, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO
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.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE BOLUS REMINDER ON THE INSULIN PUMP DOESN'T FUNCTION PROPERLY. THEY HEAR THREE CONSECUTIVE BEEPS WHEN THEY CHECK THE BLOOD GLUCOSE ON THE DEVICE, WHICH OCCURS ABOUT TEN TIMES A DAY. SHE STATED THAT SHE HAS HER OLD INSULIN PUMP NEAR BY, BUT THAT'S NOT THE PROBLEM, SINCE THE BEEPING OCCURS WHEN SHE IS IN HER OFFICE AND THE OLD DEVICE IS NOT IN THAT ROOM. SHE STATED THIS WAS THE SECOND DEVICE WITH THE SAME PROBLEM. SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE A FEW DAYS PRIOR TO THE PHONE CALL; WOKE UP WITH READINGS OF 152 MG/DL, CORRECTED WITH BOLUS. SYMPTOMS WERE NAUSEA, DRY MOUTH, AND THIRST. HER BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 102 MG/DL. SHE STATED SHE HAD SOME MEDICAL ISSUES AND IS GOING THROUGH MENOPAUSE. THE DRIVE SUPPORT CAP WAS RECESSED, SETTINGS WERE CORRECT, PASSED HIGH PRESSURE AND SELF TEST. FOUND AN ERROR ALARM IN THE HISTORY. THE FILL CANNULA WAS SET TO 2.3 UNITS INSTEAD OF 0.0 UNITS. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
430055	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523LNAP

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization