FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN CARTRIDGE

MDR report key: 4697726 · Received April 16, 2015

Report

Report Number: 2531779-2015-12765
Event Type: Malfunction
Date Received: April 16, 2015
Report Date: April 6, 2015
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: P130007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 - SUBMISSION DATE 04/30/2015; CORRECTION TO: THE CORRECT BRAND NAME IS ANIMAS INSULIN CARTRIDGE. THE CORRECT COMMON DEVICE NAME IS INSULIN PUMP CARTRIDGE. THE CORRECT MODEL# IS ANIMAS IR1200/1250/2020/OTP CART; THE CORRECT SERIAL# IS NI. THE CORRECT PMA/510(K) # IS K032257. THE CORRECT DEVICE MANUFACTURING DATE IS UNK. THE CORRECT LABELED FOR SINGLE USE IS ¿YES¿. THE CORRECT DEVICE IS ¿THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION.¿

Description of Event or Problem · 1

ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, THE PUMP ALERTED FOR LOSS OF PRIME MULTIPLE TIMES. THE REPORTER COMPLETED PRIME STEP WITH CARTRIDGE CHANGE. NO SUDDEN CHANGE IN FORCE OR TEMPERATURE WAS NOTED AND THE CARTRIDGE CAP WAS SECURED PROPERLY. REVIEW OF CARTRIDGE USE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE WAS FOLLOWED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
254125	ANIMAS INSULIN CARTRIDGE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR