FDA Adverse Event Malfunction Summary report: N

640G INSULIN PUMP MMT-1712K

MDR report key: 8665270 · Received June 4, 2019

Report

Report Number: 2032227-2019-10766
Event Type: Malfunction
Date Received: June 4, 2019
Date of Event: May 29, 2019
Report Date: August 30, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
UDI-DI: 00763000065201
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PO
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.

Additional Manufacturer Narrative · 1

INSULIN PUMP PASSED DISPLACEMENT TEST AND SELF TEST. THE AUDIO TONES/BEEPS FUNCTIONED PROPERLY. NO UNEXPECTED DEVICE TEST FAILED ALARM NOTED DURING TESTING.(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THEIR INSULIN PUMP HAD A BEEP ANOMALY AND THE INSULIN PUMP FAILED AUDIO TEST. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING STEPS WERE PROVIDED FOR AUDIO ANOMALY. CUSTOMER REPORTS THEY DID NOT HEAR BEEPS WHEN AUDIO VOLUME SETTINGS WERE SAVED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
461052	640G INSULIN PUMP MMT-1712K	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1712K	A000414011	00763000065201

Patients

Seq	Age	Sex	Outcome	Treatment
1