PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

Report

• Report Number: 2032227-2015-65677
• Event Type: Injury
• Date Received: November 13, 2015
• Date of Event: October 17, 2015
• Report Date: November 2, 2015
• Manufacturer: MEDTRONIC MINIMED
• Product Code: OYC
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

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'S HUSBAND REPORTED VIA PHONE CALL THAT HIS WIFE'S BLOOD GLUCOSE WAS 576 MG/DL AND THAT IT AT ONE POINT EXCEEDED 600 MG/DL. THE CUSTOMER TREATED WITH A PUMP BOLUS. NO PRODUCTS WERE SHIPPED OR RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
753093	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-523NAB

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Other

Terms

Patient problem · 1

• Hyperglycemia

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• OTHER