FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 2903881 · Received January 9, 2013

Report

Report Number: 2531779-2013-00416
Event Type: Malfunction
Date Received: January 9, 2013
Report Date: December 10, 2012
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

THE PUMP WAS RETURNED FOR INVESTIGATION. DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ALL LOSS OF PRIMES IN THE BLACK BOX WERE ASSOCIATED WITH REWINDS AND CARTRIDGE RELOADS. TESTING PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO LOSS OF PRIME. PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF PRIME. FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATION, LOW . REMOVED PUMP FROM CASE AND REMOVED FORCE SENSOR PLATE. FORCE SENSOR SHIM PLATE WAS CONTAMINATED. FORCE SENSOR RESISTANCE WAS OUT OF SPECIFICATION. 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.

Description of Event or Problem · 1

THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CONTAMINATED FORCE SENSOR, A FORCE SENSOR HIGH, AND BAD FORCE SENSOR CALIBRATION (LOW). THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
11035	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ANM 2020 INSULIN INFUSION PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1