FDA Adverse Event Injury Summary report: N

530G INSULIN PUMP

MDR report key: 4813511 · Received June 2, 2015

Report

Report Number: 3004209178-2015-61804
Event Type: Injury
Date Received: June 2, 2015
Date of Event: May 12, 2015
Report Date: May 13, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
PMA / PMN Number: 120010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL
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

THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED WITH HIGH BLOOD GLUCOSE ON (B)(6) 2015. THE CUSTOMER'S BLOOD GLUCOSE WAS 571 MG/DL AT THE TIME OF ADMISSION. CUSTOMER STATED THEY WERE VOMITING FROM THEIR HIGH BLOOD GLUCOSE. THE CUSTOMER ATTEMPTED TO TREAT THEIR BLOOD GLUCOSE WITH THE INSULIN PUMP, BUT THEIR BLOOD GLUCOSE WOULD NOT DECLINE. THE CAUSE OF THE CUSTOMER'S HOSPITALIZATION WAS FROM DIABETIC KETOACIDOSIS. THE CUSTOMER WAS TREATED WITH AN IV DRIP FOR THEIR BLOOD GLUCOSE. THE CUSTOMER WAS CONNECTED TO THE INSULIN PUMP AT THE TIME OF THEIR HOSPITALIZATION. IT WAS ALSO FOUND THE CUSTOMER RECEIVED A NO DELIVERY ALARM WHEN ATTEMPTING TO DELIVER INSULIN TO THEIR BODY. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES ON THE INSULIN PUMP DURING TROUBLESHOOTING. CUSTOMER ALSO DECLINED TO CHECK FOR THEIR SETTINGS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
355812	530G INSULIN PUMP	OZO	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-751NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR		Hospitalization