FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3213901 · Received July 9, 2013

Report

Report Number: 2531779-2013-10032
Event Type: Malfunction
Date Received: July 9, 2013
Report Date: June 24, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 09/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2013 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. WHEN REPLACED WITH A TEST DISPLAY, THE SCREEN FUNCTIONED PROPERLY.

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A GRADUAL DIM/FADING DISPLAY SCREEN ISSUE. THE REPORTER INDICATED DIFFICULTY SEEING THE DISPLAY. THE REPORTER NOTED THAT THE PATIENT IS ABLE TO READ THE SCREEN SAFELY AND CONTINUES TO USE THE PUMP. 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. A REPLACEMENT PUMP WILL BE SENT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
313153	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 YR