FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 4251837 · Received November 14, 2014

Report

Report Number: 2531779-2014-32700
Event Type: Malfunction
Date Received: November 14, 2014
Report Date: October 27, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K042873
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
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. ANIMAS HAS 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.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/31/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED IN TWO PLACES. ONE CRACK WAS AT THE TOP OF THE COMPARTMENT, AND THE OTHER WAS JUST BELOW THE BUMPER PAD. THE RETURNED BATTERY CAP WAS CONFIRMED TO BE ABLE TO TIGHTEN FULLY TO THE PUMP.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE BATTERY COMPARTMENT WAS DAMAGED. THE REPORTER CONFIRMED THAT THERE WAS NO NOTED MOISTURE OR CORROSION INSIDE THE PUMP RELATED TO THE COMPLAINT. 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
737117	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 YR