FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN CARTRIDGE

MDR report key: 2760640 · Received September 26, 2012

Report

Report Number: 2531779-2012-11272
Event Type: Malfunction
Date Received: September 26, 2012
Report Date: August 30, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K032257
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201841 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

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.

Description of Event or Problem · 1

THE PATIENT CLAIMED HE MOISTURE DROPLETS INSIDE THE CARTRIDGE COMPARTMENT AND CARTRIDGE CHAMBER NEAR THE PLUNGER END. THE PATIENT ADMITTED HE USED COLD INSULIN AND WANTED TO KNOW IF THE MOISTURE DROPLETS ARE DUE TO CONDENSATION. THERE IS NO MISSING INSULIN. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO A POTENTIAL LEAKAGE IN THE CARTRIDGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN CARTRIDGE	INSULIN PUMP CARTRIDGE	LZG	ANIMAS CORPORATION	ANM IR1200/1250/2020/OTP CART	B201841

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR