FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN CARTRIDGE

MDR report key: 8261933 · Received January 18, 2019

Report

Report Number: 2531779-2019-00569
Event Type: Malfunction
Date Received: January 18, 2019
Report Date: January 18, 2019
Manufacturer: ANIMAS LLC
Product Code: OYC
PMA / PMN Number: K032257
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: 003

Narratives

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.

Additional Manufacturer Narrative · 1

CORRECTION: THE PRODUCT PREVIOUSLY REPORTED WAS A PUMP. THE CORRECT PRODUCT IS THE CARTRIDGE. BRAND NAME: ANIMAS INSULIN CARTRIDGE. COMMON DEVICE NAME: ANIMAS INSULIN CARTRIDGE. MODEL # ANM IR1200/1250/2020 CART. PMA/510(K)#: K032257. 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) 2019, THE REPORTER ALLEGED THE PUMP EXPERIENCED AN ISSUE WITH LOSS OF PRIME. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
54981	ANIMAS INSULIN CARTRIDGE	INSULIN INFUSION PUMP	OYC	ANIMAS LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR