FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 2202529 · Received August 5, 2011

Report

Report Number: 3004209178-2011-82458
Event Type: Injury
Date Received: August 5, 2011
Date of Event: July 26, 2011
Report Date: July 26, 2011
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 400MG/DL. IT WAS STATED THAT THE MOTHER CALLED THE DOCTOR WHO SUGGESTED TREATING THE CUSTOMER'S BLOOD GLUCOSE WITH MANUAL INJECTIONS. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST TWO DAYS. IT WAS STATED THAT THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 363MG/DL, AND SHE WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND THE TESTS PASSED. IT WAS STATED THAT THE CUSTOMER HAS NOTICED BENT CANNULAS OFTEN. EXPLAINED TO THE CALLER THAT WHEN INSERTING THE MIO INFUSION SET, THE SKIN SHOULD NOT BE PINCHED, INSTEAD IT SHOULD BE LAID FLAT ON THE SKIN'S SURFACE WITH A LIGHT AMOUNT OF PRESSURE. NO FURTHER INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	MDS	MEDTRONIC PUERTO RICO OPERATIONS MED-REL	MMT-723NAB

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR		Hospitalization	UNOMEDICAL INFUSION SET: (B)(4)\| SILHOUETTE 23"