FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3945816 · Received July 21, 2014

Report

Report Number: 3004209178-2014-87982
Event Type: Malfunction
Date Received: July 21, 2014
Date of Event: June 19, 2014
Report Date: June 19, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

INSULIN PUMP PASSED DISPLACEMENT TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM. MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND CRACKED BELT CLIP SLOT.

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

IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY. CUSTOMER STATES THAT THEY NOTICED A CRACK FROM THE BOTTOM OF THE DEVICE NEAR THE SERIAL NUMBER TO THE RESERVOIR COMPARTMENT AND BATTERY CAP. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 168 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
425749	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR