FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3855132 · Received June 9, 2014

Report

Report Number: 2531779-2014-16208
Event Type: Malfunction
Date Received: June 9, 2014
Report Date: June 2, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 DATE OF SUBMISSION 07/09/2014-PRODUCT ANALYSIS:THE PUMP AND BATTERY CAP WERE RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/30/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED RELATED ALARMS. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM.

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.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) 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
335385	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR