FDA Adverse Event Malfunction Summary report: N

640G INSULIN PUMP MMT-1712K

MDR report key: 8905360 · Received August 19, 2019

Report

Report Number: 2032227-2019-48689
Event Type: Malfunction
Date Received: August 19, 2019
Date of Event: August 10, 2019
Report Date: November 11, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
UDI-DI: 00763000192143
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. ALL AUDIO TONES WERE HEARD DURING THE SELF TEST PROPERLY. ADJUSTED THE AUDIO OPTIONS AUDIO VOLUME 1-5 AND EACH SETTING FUNCTIONED PROPERLY. NO UNEXPECTED AUDIO OR VIBRATION ANOMALIES NOTED. NO PUMP ERROR 63 NOTED DURING SELF TEST OR IN DEVICE HISTORY FILES. (B)(4).

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

IT WAS REPORTED THAT THERE WERE WRONG AUDIO SIGNALS FOR DIFFERENT ALARMS. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE INSULIN PUMP SEEMS TO MIX UP THE SIGNALS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
701243	640G INSULIN PUMP MMT-1712K	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1712K	HG34V19	00763000192143

Patients

Seq	Age	Sex	Outcome	Treatment
1