FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS

MDR report key: 8645220 · Received May 28, 2019

Report

Report Number: 2032227-2019-08055
Event Type: Malfunction
Date Received: May 28, 2019
Date of Event: May 16, 2019
Report Date: July 10, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
UDI-DI: 00763000161279
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KU
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 PARADIGM REAL-TIME VEO 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

DEVICE RECEIVED WITH MISSING SEGMENTS/PARTIAL DISPLAY DUE TO CRACKED AND BLEEDING LCD GLASS. UNABLE TO PERFORM SELF-TEST AND DISPLACEMENT TEST DUE TO MISSING SEGMENTS/PARTIAL DISPLAY.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LCD SCREEN CAN NOT BE SEEN DUE TO CRACK. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER CONFIRMED THAT THE PUMP WAS DROPPED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
439916	PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-754LWWS	A5754LWWSJ	00763000161279

Patients

Seq	Age	Sex	Outcome	Treatment
1