FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 1942353 · Received December 22, 2010

Report

Report Number: 2531779-2010-03007
Event Type: Malfunction
Date Received: December 22, 2010
Date of Event: November 21, 2010
Report Date: November 21, 2010
Manufacturer: ANIMAS CORP.
Product Code: LZG
PMA / PMN Number: K042873
Removal / Correction Number: 2531779-03/24/2010-003-R
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. EVAL REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PUMP DISPENSED 63 UNITS OF INSULIN DURING THE LOAD CARTRIDGE PHASE OF A ROUTINE CARTRIDGE CHANGE. THE PATIENT STATED THAT THE EVENT OCCURRED SEVERAL TIMES OVER THE PAST TWO WEEKS. HE ADDITIONALLY REPORTED THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIME WARNINGS DURING THE SAME TIME PERIOD. HE NOTED THAT THE CARTRIDGE CAP WAS SECURE, THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, THE PUMP DID NOT REBOOTED WITHOUT INTERVENTION, THE BATTERY WAS NOT REMOVED WITHOUT COMPLETING THE EZPRIME STEPS, THE CARTRIDGE WAS REPLACED SEVERAL TIMES, AND THERE WERE NO RELEVANT ALARMS IN HISTORY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORP.	ANIMAS 2020

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR