FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3895672 · Received June 25, 2014

Report

Report Number: 2531779-2014-18269
Event Type: Malfunction
Date Received: June 25, 2014
Report Date: June 23, 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 08/04/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A PEELING KEYPAD. DURING TESTING, THE OK KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CORROSION DUE TO MOISTURE WAS FOUND UNDER ALL OF THE KEYPAD BUTTON CONTACTS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED. THERE WAS EVIDENCE OF MOISTURE CORROSION ON KEYPAD FLEX, AND A LEAK TEST CONFIRMED A DISPLAY LENS LEAK.

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 THE KEYPAD WAS DAMAGED AND ALL KEYPAD BUTTONS WERE UNDER-RESPONSIVE. IT WAS REPORTED THE DAMAGE OCCURRED PRIOR TO THE RESPONSE 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
372059	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR