FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN CARTRIDGE

MDR report key: 3760472 · Received April 21, 2014

Report

Report Number: 2531779-2014-10658
Event Type: Malfunction
Date Received: April 21, 2014
Report Date: April 4, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K032257
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 05/13/2014-DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON 04/30/2014 WITH THE FOLLOWING FINDINGS:A RETAIN SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL TEST WERE PERFORMED WITH NO FAILURES OBSERVED.

Additional Manufacturer Narrative · 1

THE DEVICE 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. 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.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER STATED THAT THE PUMP EMITTED TWO LOSS OF PRIME WARNINGS. 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
240381	ANIMAS INSULIN CARTRIDGE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION		D200028

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR