FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3972363 · Received July 31, 2014

Report

Report Number: 3004209178-2014-88706
Event Type: Injury
Date Received: July 31, 2014
Date of Event: July 23, 2014
Report Date: July 23, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

Description of Event or Problem · 1

CUSTOMER REPORTED HOSPITALIZATION DUE TO PAIN ACROSS SHOULDERS AND STOMACH AS WELL AS HIGH BLOOD GLUCOSE READINGS. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS 500 MG/DL. CUSTOMER'S BLOOD GLUCOSE READINGS WERE DECREASED AND SHE WAS RELEASED FROM THE HOSPITAL. CUSTOMER STATED THAT WHEN THEY WENT TO SLEEP THEIR BLOOD GLUCOSE READINGS INCREASED FROM 265 MG/DL TO 485 MG/DL. CUSTOMER BELIEVES THERE IS SOMETHING WRONG WITH THE INSULIN PUMP. CUSTOMER TREATED THE HIGH WITH A MANUAL INJECTION. NO FURTHER INFORMATION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
448953	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Hospitalization