FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 2200759 · Received July 27, 2011

Report

Report Number: 3004209178-2011-82301
Event Type: Injury
Date Received: July 27, 2011
Date of Event: July 11, 2011
Report Date: July 13, 2011
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ND, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF MORE THAN 500MG/DL. IT WAS STATED THAT THE INFUSION SET TUBING CAME OUT WHEN TUBING WAS SNAGGED WHILE PLAYING, AND THE CUSTOMER'S BLOOD GLUCOSE HAS BEEN HIGH SINCE THEN. IT WAS ALSO STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST TWO DAYS. IT WAS STATED THAT THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 385MG/DL, AND SHE WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. IT WAS STATED THAT THE CUSTOMER NOTICES BENT CANNULAS. 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-522NAP

Patients

Seq	Age	Sex	Outcome	Treatment
1	6 YR		Hospitalization	PARADIGM: 6MM CATHETER\| QUICK-SET: 23\| 6MM CATHETER\| UNOMEDICAL INFUSION SET: MMT-399