FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4790937 · Received May 22, 2015

Report

Report Number: 3004209178-2015-58532
Event Type: Malfunction
Date Received: May 22, 2015
Date of Event: May 1, 2015
Report Date: May 2, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE PUMP GAVE AN ALARM DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO COMPLETE THE PRIME/FILL PROCESS OR TEST THE ALARM/ALERT ICON DUE TO THE PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE PUMP ALSO HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW.

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Description of Event or Problem · 1

CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING PRIME AND INSULIN WAS SQUIRTING OUT OF THE TUBING. THE INSULIN PUMP WAS NOT BUMPED OR DROPPED. THE DRIVE SUPPORT CAP IS PROTRUDED. BLOOD GLUCOSE VALUE WAS 210 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. CUSTOMER WAS ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
334036	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAH

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR