FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3981239 · Received August 5, 2014

Report

Report Number: 2531779-2014-22448
Event Type: Malfunction
Date Received: August 5, 2014
Report Date: July 30, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/03/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH NO VISIBLE DAMAGE TO THE KEYPAD COVER. DURING TESTING, THE OK, UP AND DOWN ARROW KEYPAD BUTTONS WERE UNRESPONSIVE DUE TO A DAMAGED AUDIO BOLUS BUTTON CONTACT. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY OF THE KEYPAD BUTTON CONTACTS. THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE BOLUS BUTTON COVER WAS REMOVED AND THE CONTACT WAS FOUND TO BE DAMAGED AND STUCK IN THE ON POSITION.

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 BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE OK, UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE UNDER-RESPONSIVE. 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
458157	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR