FDA Adverse Event Malfunction Summary report: N

PUMP MMT-1714K 630G BLACK MMOL CANADA

MDR report key: 8825560 · Received July 25, 2019

Report

Report Number: 2032227-2019-35952
Event Type: Malfunction
Date Received: July 25, 2019
Date of Event: July 17, 2019
Report Date: October 1, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
UDI-DI: 00763000253059
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE RECEIVED WITH A CONSTANT BLANK FLASHING WHITE LIGHT ON THE DISPLAY DUE TO VERTICAL CRACKED LCD CONTROLLER. UNABLE TO VERIFY MISSING SEGMENTS OR PARTIAL DISPLAY AND PERFORM THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST DUE TO A CONSTANT BLANK FLASHING WHITE LIGHT ON THE DISPLAY.

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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP HAD A FLASHING A WHITE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 5.9 MMOL/L AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
619430	PUMP MMT-1714K 630G BLACK MMOL CANADA	ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1714K	A000684495	00763000253059

Patients

Seq	Age	Sex	Outcome	Treatment
1