FDA Adverse Event Injury Summary report: N

630G INSULIN PUMP MMT-1715K 630G BLACK MG

MDR report key: 7543721 · Received May 25, 2018

Report

Report Number: 3004209178-2018-73919
Event Type: Injury
Date Received: May 25, 2018
Date of Event: May 3, 2018
Report Date: May 24, 2018
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
UDI-DI: 00643169656840
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
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 EXPERIENCED HIGH BLOOD GLUCOSE OF 415 MG/DL. THE CUSTOMER BLOOD GLUCOSE WAS 207 MG/DL AT TIME OF INCIDENT. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE IS 416 MG/DL. THE OTHER RELEVANT BLOOD GLUCOSE VALUES WERE 70, 170, 105, 176, 165, 161, 306, 320, 396 AND 443 MG/DL GAVE MANUAL INJECTION AND THE BLOOD GLUCOSE WENT DOWN TO 382 MG/DL. THE CUSTOMER TREATED WITH THE PUMP. THE CUSTOMER ALSO STATES THE BOLUS NOT DELIVERED AND DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
386196	630G INSULIN PUMP MMT-1715K 630G BLACK MG	ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1715K	HG2C6HN	00643169656840

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Other