FDA Adverse Event Malfunction Summary report: N

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

MDR report key: 8806990 · Received July 19, 2019

Report

Report Number: 2032227-2019-32922
Event Type: Malfunction
Date Received: July 19, 2019
Date of Event: July 9, 2019
Report Date: September 18, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZP
UDI-DI: 00643169939219
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS RECEIVED WITH CRITICAL PUMP ERROR AFTER BATTERY INSTALLATION AND UNABLE TO DOWNLOAD DUE TO CORRODED ELECTRONIC ASSEMBLY. CORRODED MOTOR ASSEMBLY NOTED DURING VISUAL INSPECTION. UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING SELF TEST, REWIND, PRIMEOR SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR.

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

THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 68 MG/DL. CUSTOMER STATED THEY DO HEAR FLUID WHEN SHAKING THE INSULIN PUMP. CUSTOMER STATED THERE ARE NOT CRACKS IN THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
602443	PUMP MMT-1780KPK 670G PATHWAY BLACK MG	ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL	OZP	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1780KPK	HG27FFW	00643169939219

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR