FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 2202531 · Received August 5, 2011

Report

Report Number: 3004209178-2011-82466
Event Type: Injury
Date Received: August 5, 2011
Date of Event: July 25, 2011
Report Date: July 25, 2011
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, 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

THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 437MG/DL, AND SHE HAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, DATE, AND TIME WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. THE CUSTOMER CALLED BACK AND STATED THAT HER BLOOD GLUCOSE WENT UP TO 553MG/DL, AND SHE WAS TREATING WITH THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE ENTERED HER GLUCOSE READING IN THE PUMP AND GAVE HERSELF A BOLUS. WHILE ON CALL, THE PARAMEDICS WERE CONTACTED. INSTRUCTED CUSTOMER TO CHECK AGAIN AND HER BLOOD GLUCOSE DROPPED TO 502MG/DL. ATTEMPTED LATER TO CONTACT CUSTOMER TO OBTAIN MORE INFO SURROUNDING THE EVENT, AND WAS NOT ABLE TO REACH. NO FURTHER INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	MDS	MEDTRONIC PUERTO RICO OPERATIONS MED-REL	MMT-522NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR			UNOMEDICAL INFUSION SET: (B)(4)\| QUICK-SET: 23\| PARADIGM 9MM CATHETER