FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 4760190 · Received May 8, 2015

Report

Report Number: 2531779-2015-15492
Event Type: Malfunction
Date Received: May 8, 2015
Report Date: April 27, 2015
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #1; DATE OF SUBMISSION: 06/26/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 06/10/2015 WITH THE FOLLOWING FINDINGS:INSPECTION REVEALED THAT THE DISPLAY SCREEN VISUAL WAS DIM AND DISCOLORED: THE REPORTED ISSUE WAS CONFIRMED. THE REPORTED ISSUE WAS DIRECTLY CAUSED BY AN UNIDENTIFIED DISPLAY FAILURE. THE FOLLOWING FINDINGS ARE UNRELATED TO THE REPORTED ISSUE: THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED IN THE AREA BELOW THE GRIP PAD. THE CARTRIDGE COMPARTMENT WAS FOUND TO BE CRACKED IN THE THREAD AREA.

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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN VISUAL WAS DIM, FADED, OR DISCOLORED. IN ADDITION, IT WAS REPORTED THAT THE USER COULD NOT READ THE DISPLAY SCREEN SAFELY. 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
303773	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR