FDA Adverse Event Injury Summary report: N

530G INSULIN PUMP

MDR report key: 3972229 · Received July 31, 2014

Report

Report Number: 3004209178-2014-88641
Event Type: Injury
Date Received: July 31, 2014
Date of Event: July 1, 2014
Report Date: July 1, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
PMA / PMN Number: 120010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PATIENT

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 THE DAY PRIOR FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS ADMITTED TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE READING OF 535 MG/DL AND WAS RELEASED WITH A BLOOD GLUCOSE READING OF 371 MG/DL. AFTER AN INFUSION SET CHANGE, SHE RECEIVED INSULIN AND WOKE UP WITH A BLOOD GLUCOSE READING OF 335 MG/DL. THE CUSTOMER STATED THAT SHE CHANGED TO HER OLD INSULIN PUMP AND THE BLOOD GLUCOSE READING WAS 290 MG/DL. THE BLOOD GLUCOSE READING WAS 230 MG/DL AT THE TIME OF THE CALL. SHE TREATED USING THE INSULIN PUMP AS WELL AS MANUAL INJECTION. NO SIGNIFICANT EVENTS LEADING TO THE HOSPITALIZATION WERE OBSERVED. THE CUSTOMER HAD NOT BEEN WEARING THE INSULIN PUMP FOR 4 HOURS AT THE TIME OF THE EMERGENCY ROOM VISIT. UPON TROUBLESHOOTING, INSULIN DID EXIT FROM THE TUBING DURING A MANUAL PRIME. NO LEAK WAS FOUND. THE DEVICE PASSED THE HIGH PRESSURE TEST. ADVISED THE DEVICE WAS WORKING AS DESIGNED. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
447766	530G INSULIN PUMP	OZO	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-551NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Hospitalization