FDA Adverse Event Malfunction Summary report: N

SENSOR MMT-7020A ENLITE3 5PK US

MDR report key: 8622160 · Received May 18, 2019

Report

Report Number: 3004209178-2019-98917
Event Type: Malfunction
Date Received: May 18, 2019
Date of Event: May 14, 2019
Report Date: February 18, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZP
UDI-DI: 20763000140940
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Additional Manufacturer Narrative · 1

INSPECTED ONE OPENED AND USED SENSOR AND PERFORMED CONTINUITY RESISTANCE TEST AND SENSOR FAILED TEST. FOUND CANNULA BENT UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED AND USED.

Description of Event or Problem · 1

CUSTOMER¿S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 190 MG/DL AND THE SENSOR GLUCOSE WAS 49 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. CUSTOMER STATES THE SENSOR VALUE THAT TRIGGERED THE SUSPEND ON LOW OR SUSPEND BEFORE LOW EVENT WAS 49 MG/DL. LOW LIMIT IN SENSOR SETTINGS WAS UNKNOWN. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANG. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
415489	SENSOR MMT-7020A ENLITE3 5PK US	ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL	OZP	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-7020A	HG32DV3	20763000140940

Patients

Seq	Age	Sex	Outcome	Treatment
1	14 YR