FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3760668 · Received April 21, 2014

Report

Report Number: 2531779-2014-10668
Event Type: Malfunction
Date Received: April 21, 2014
Report Date: April 6, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 05/12/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/02/2014 WITH THE FOLLOWING RESULTS:A VISUAL INSPECTION OF THE PUMP CONFIRMED THAT THE KEYPAD COVER WAS INTACT WITH NO DAMAGE. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS OPENED AND NO CONTAMINATION WAS FOUND. UNRELATED TO THE COMPLAINT, THE PUMP FAILED AN IN HOUSE LEAK TEST. A BATTERY COMPARTMENT CRACK WAS FOUND AND MOISTURE INGRESS WAS VISIBLE IN THE COMPARTMENT AND THE BATTERY CAP. THE PUMP COVER WAS OPENED AND INTERNAL MOISTURE WAS FOUND IN THE PUMP.

Additional Manufacturer Narrative · 1

THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS ALLEGED THAT THERE WAS A RESPONSE ISSUE WITH THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS. 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
240253	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR