FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4111454 · Received September 23, 2014

Report

Report Number: 2032227-2014-28000
Event Type: Malfunction
Date Received: September 23, 2014
Date of Event: August 25, 2014
Report Date: August 25, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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

THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME, AND DISPLACEMENT TESTS. THE DEVICE WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. THE DEVICE HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT, AND CRACKED RESERVOIR TUBE LIP.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT'S SENSOR INSULIN PUMP DISPLAYED A MOTOR ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE CAUSES FOR THE ALARM. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
589794	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-722WWS

Patients

Seq	Age	Sex	Outcome	Treatment
1	114 YR