FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3251032 · Received July 29, 2013

Report

Report Number: 2531779-2013-11988
Event Type: Malfunction
Date Received: July 29, 2013
Report Date: July 2, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 10/14/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/27/2013 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP POWERED ON NORMALLY WITH A FUNCTIONAL DISPLAY AND NORMAL AUDIBLE AND VIBRATORY TONES. EVIDENCE OF MOISTURE WAS VISIBLE BEHIND THE DISPLAY LENS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR ALARMS. THE PUMP¿S HISTORY COULD NOT BE DOWNLOADED DUE TO THE MOISTURE INGRESS. THE PUMP COVER WAS OPENED AND EVIDENCE OF MOISTURE WAS FOUND ON THE INTERNAL CIRCUIT BOARD. 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.

Description of Event or Problem · 1

ON (B)(6) 2013, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF THE PATIENT, ALLEGING A POWER ISSUE. THE SUBJECT PUMP WILL NOT POWER ON AFTER THE PATIENT WENT SWIMMING. IT WAS NOTED THERE WAS WATER UNDER THE DISPLAY SCREEN. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
351962	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR