FDA Adverse Event Malfunction Summary report: N

SENSOR ENLITE MMT-7008A

MDR report key: 8685780 · Received June 11, 2019

Report

Report Number: 2032227-2019-14146
Event Type: Malfunction
Date Received: June 11, 2019
Date of Event: May 29, 2019
Report Date: November 20, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
UDI-DI: 20643169786725
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 RANDOM OPENED/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/USED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 110 MG/DL AND THE SENSOR GLUCOSE WAS 60 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT 60 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 70 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
482179	SENSOR ENLITE MMT-7008A	ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-7008A	HG36XTT	20643169786725

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR