FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3252364 · Received July 29, 2013

Report

Report Number: 2531779-2013-12022
Event Type: Malfunction
Date Received: July 29, 2013
Report Date: July 6, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1: DATE OF SUBMISSION 10/24/2013. DEVICE EVALUATION:THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/15/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP HISTORY SHOWED NO OCCLUSION ALARMS WERE RECORDED. THE PUMP REWIND, LOAD, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO OCCLUSIONS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO OCCLUSIONS. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. DURING TESTING THE PUMP WAS REWOUND, LOADED, AND PRIMED. OCCLUSION ALARMS WERE EMITTED WHEN THE PUMP ATTEMPTED TO DELIVER BOLUSES. THE PUMP WAS OPENED AND THERE WAS NO DEFECT FOUND.

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (ABSENCE OF OCCLUSION ALARM) ISSUE. IT WAS REPORTED THAT THE PUMP WAS NOT GIVING OCCLUSION ALARMS FOR BENT CANNULAS. 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
352913	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 YR