FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3972352 · Received July 31, 2014

Report

Report Number: 3004209178-2014-88791
Event Type: Malfunction
Date Received: July 31, 2014
Date of Event: July 1, 2014
Report Date: July 1, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. NO MOTOR ERROR ALARM WAS NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS.

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 THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BOLUS PROCESS. THE BLOOD GLUCOSE READING WAS 181 MG/DL. THE CUSTOMER STATED THAT SHE HAD HAD SURGERY ON HER SHOULDER AND HAD REMOVED THE INSULIN PUMP WHEN THE ALARM OCCURRED. THIS WAS THE FIRST TIME THE DEVICE HAD ALARMED MOTOR ERROR, AND IT HAD NOT BEEN BUMPED NOR DROPPED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
448609	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523LNAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR