FDA Adverse Event Malfunction Summary report: N

640G INSULIN PUMP MMT-1712K

MDR report key: 8805970 · Received July 19, 2019

Report

Report Number: 2032227-2019-32325
Event Type: Malfunction
Date Received: July 19, 2019
Date of Event: June 30, 2019
Report Date: July 18, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
UDI-DI: 00643169999770
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
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. 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.

Description of Event or Problem · 1

CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF OVER 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN MANUAL INJECTIONS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS VOMITING, ABDOMINAL PAIN, AND DIFFICULTY BREATHING. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER BELIEVES THE PUMP WAS UNDER DELIVERING. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED, AND THE PUMP FAILED A SELF TEST WITH A HARDWARE LOW LEVEL FAILURES ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
601922	640G INSULIN PUMP MMT-1712K	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1712K	HG24BQJ	00643169999770

Patients

Seq	Age	Sex	Outcome	Treatment
1