FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 4222229 · Received November 3, 2014

Report

Report Number: 2531779-2014-31307
Event Type: Malfunction
Date Received: November 3, 2014
Report Date: October 17, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K042873
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/23/2014 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A LOSS OF PRIME ASSOCIATED WITH A LOW, NON-ZERO FORCE. DURING TESTING, THE PUMP EMITTED AN OCCLUSION ALARM WITH AN ATTEMPTED LOAD STEP WHILE A CARTRIDGE WAS NOT IN THE COMPARTMENT AND THE PISTON STOPPED AT THE 205 UNIT MARK. FURTHER ADEQUATE INVESTIGATION OF THE LOSS OF PRIME COMPLAINT COULD NOT BE DUPLICATED. THE PUMP CASE WAS REMOVED, AND THE U4 COMPONENT ON THE PRINTED CIRCUIT BOARD WAS FOUND TO BE MISALIGNED. (B)(4).

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. (B)(6)

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. 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
702337	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1