FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 3121015 · Received May 20, 2013

Report

Report Number: 3004209178-2013-93655
Event Type: Malfunction
Date Received: May 20, 2013
Date of Event: May 15, 2013
Report Date: May 15, 2013
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP WAS RECEIVED WITH LOOSE/FLUSH DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED LCD WINDOW. THE INSULIN PUMP WAS RECEIVED WITH A 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS LOPSIDED, AND IT HAPPENED A MONTH AGO. THE BLOOD GLUCOSE READING WAS 6.6MMOL/L. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS FLUSH. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
222629	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-754CAH

Patients

Seq	Age	Sex	Outcome	Treatment
1