FDA Adverse Event Malfunction Summary report: N

530G INSULIN PUMP MMT-751NAS

MDR report key: 8806890 · Received July 19, 2019

Report

Report Number: 2032227-2019-32894
Event Type: Malfunction
Date Received: July 19, 2019
Date of Event: July 4, 2019
Report Date: September 3, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
UDI-DI: 00643169503717
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, 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

NO MISSING SEGMENT/PARTIAL DISPLAY ANOMALY NOTED DURING TESTING. HOWEVER, DEVICE HAD SEVERELY SCRATCHED LCD WINDOW. DEVICE RECEIVED A33 ALARM DURING THE BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST DUE TO A33 ALARM. HOWEVER, DEVICE PASSED REWIND TEST AND DISPLACEMENT TEST.

Description of Event or Problem · 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND CANNOT READ THE SCREEN ON INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 379 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED PUMP DID REQUIRE REWIND. CUSTOMER ABLE TO COMPLETE REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
600100	530G INSULIN PUMP MMT-751NAS	ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-751NAS	A4751NASJ	00643169503717

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR