FDA Adverse Event Injury Summary report: N

PARADIGM INSULIN INFUSION PUMP

MDR report key: 2234127 · Received August 30, 2011

Report

Report Number: 3004209178-2011-82762
Event Type: Injury
Date Received: August 30, 2011
Date of Event: August 17, 2011
Report Date: August 17, 2011
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNK 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 THAT WHILE SHE WAS PRIMING A FEW DROPS OF INSULIN DID EXIT. THE CUSTOMER STATED THAT SHE NOTICED THE RESERVOIR WAS EMPTY, AND SHE HAD 89.0 UNITS OF INSULIN WHEN SHE STARTED. THE CUSTOMER'S GLUCOSE READING WAS 248 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT FIVE MINUTES LATER HER GLUCOSE LEVEL DROPPED TO 239 MG/DL. ADVISED THE CUSTOMER TO SEEK A MEDICAL ATTENTION. A FOLLOW UP WAS COMPLETED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 165 MG/DL WHEN SHE ARRIVED TO THE HOSPITAL. THE CUSTOMER WAS RELEASED BUT SHE WAS NOT TREATED AT THE HOSPITAL. THE CUSTOMER STATED THAT WHEN SHE GOT HOME HER BLOOD GLUCOSE DROPPED TO 33 MG/DL. THE CUSTOMER TREATED WITH FOOD AND HER GLUCOSE LEVEL ROSE. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. NO FURTHER INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PARADIGM INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	MDS	MEDTRONIC PUERTO RICO OPERATIONS MED-REL	MMT-523NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Hospitalization