FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4142077 · Received October 4, 2014

Report

Report Number: 2032227-2014-33333
Event Type: Malfunction
Date Received: October 4, 2014
Date of Event: September 5, 2014
Report Date: September 5, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE UNIT PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME, COMPROMISED FORCE SENSOR TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THERE WAS NO MOTOR ERROR ALARMS OR DISPLACEMENT ANOMALIES NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE UNIT WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND RESERVOIR TUBE LIP. THE UNIT WAS RECEIVED WITH MINOR SCRATCHED LCD 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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 173MG/DL. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
621106	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR