FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3160036 · Received June 10, 2013

Report

Report Number: 2531779-2013-08008
Event Type: Malfunction
Date Received: June 10, 2013
Report Date: May 16, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 08/06/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO DAMAGED WAS OBSERVED. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL BUTTON CONTACTS.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. REPORTEDLY, THE UP, DOWN, AND OK BUTTONS ARE NOT RESPONDING CONSISTENTLY TO USER INPUT AND REQUIRE MULTIPLE PRESSES TO ELICIT A RESPONSE. THERE IS NO DAMAGE TO THE SUBJECT PUMP. THERE IS NO EVIDENCE OF PRODUCT MISUSE, MOISTURE, OR CORROSION ASSOCIATED WITH THE REPORTED ISSUE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259449	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR