FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3850132 · Received June 4, 2014

Report

Report Number: 2531779-2014-15838
Event Type: Malfunction
Date Received: June 4, 2014
Report Date: May 29, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PATIENT

Narratives

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. 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.

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/30/2014 WITH THE FOLLOWING FINDINGS: BATTERY COMPARTMENT CRACKS WERE OBSERVED. MOISTURE WAS OBSERVED WITHIN THE BATTERY COMPARTMENT ON THE UNDERSIDE OF THE TWO RETURNED BATTERY CAPS. LEAK TESTING REVEALED A BATTERY COMPARTMENT LEAK. MOISTURE WAS OBSERVED ON THE PUMP¿S INTERNAL COMPONENTS. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE BATTERY CAP WAS DAMAGED AND THERE WAS EVIDENCE OF MOISTURE WITHIN THE BATTERY COMPARTMENT. 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
325855	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	6 YR