FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 3850006 · Received June 4, 2014

Report

Report Number: 3004209178-2014-85429
Event Type: Malfunction
Date Received: June 4, 2014
Date of Event: June 1, 2014
Report Date: June 1, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
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. 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.

Additional Manufacturer Narrative · 1

THE INSULIN PUMP RECEIVED WITH A CONSTANT ALARM DUE TO FAULTY CONNECTOR ON THE MOTHER BOARD. UNABLE TO VERIFY THE PRIME ALARM DUE TO CONSTANT ALARM. THE INSULIN PUMP RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK, CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW, CRACKED LCD WINDOW AND CRACKED BATTERY TUBE THREADS. THE DOME LABEL STICKER IS ATTACHED TO THE END CAP.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED DURING REWIND/PRIME. THE BLOOD GLUCOSE READING WAS 5.8MMOL/L. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS STICKING OUT. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
325894	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722CAL

Patients

Seq	Age	Sex	Outcome	Treatment
1