FDA Adverse Event Malfunction Summary report: N

PARADIGM INSULIN INFUSION PUMP

MDR report key: 3852402 · Received June 5, 2014

Report

Report Number: 2032227-2014-02505
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: May 9, 2014
Report Date: May 9, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: LZG
PMA / PMN Number: K040676
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INSULIN PUMP WAS RECEIVED IN WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO FLATTENED BUTTON DOME SWITCHES. THE DEVICE PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. PROGRAMMED BOLUSES AND BASAL RATES DELIVERED AND RECORDED PROPERLY. NO DELIVERY ANOMALY NOTED.

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP AUTOMATICALLY STOPPED THE BOLUS DELIVERY. THE CUSTOMER DID SET THE DUAL BOLUS OF 2.5 UNITS FOR 3 HOURS, AND THE DEVICE STOPPED BOLUSING AFTER 2 HOURS AND DELIVERED 9.0 UNITS. THE BLOOD GLUCOSE WAS CORRECT, NOT LOWER THEN USUALLY. REVIEWED THE ALARM HISTORY AND FOUND A BUTTON ERROR ALARM. THE ALARM WAS CLEARED AND THE BATTERY WAS REMOVED. AFTER INSERTING A NEW BATTERY ANOTHER ALARM OCCURRED. THE BUTTON WAS NOT PRESSED FOR THREE MINUTES OR LONGER. THE BOLUSES WERE NOT RELATED TO AMOUNTS PROGRAMMED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328572	PARADIGM INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	MEDTRONIC MINIMED	MMT-715LWWS

Patients

Seq	Age	Sex	Outcome	Treatment
1