FDA Adverse Event Malfunction Summary report: N

640G INSULIN PUMP MMT-1712K

MDR report key: 8685750 · Received June 11, 2019

Report

Report Number: 2032227-2019-14121
Event Type: Malfunction
Date Received: June 11, 2019
Date of Event: June 6, 2019
Report Date: August 5, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
UDI-DI: 00763000069001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

Additional Manufacturer Narrative · 1

DEVICE PASSED DISPLACEMENT TEST AND SELFTEST. PUMP ERROR 63 WAS PRESENT IN THE DEVICE TRACE DOWNLOAD DUE TO BROKEN TRACE AT U1 PIN 6 ON KEYPAD ASSEMBLY. TOGGLED ON AND INCREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO OR ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING.

Description of Event or Problem · 1

IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER INQUIRED ABOUT THE AUDIO ISSUE. THE AUDIO ISSUE WAS CONFIRMED DURING THE CALL. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
482171	640G INSULIN PUMP MMT-1712K	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1712K	HG28MMA	00763000069001

Patients

Seq	Age	Sex	Outcome	Treatment
1