FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3882215 · Received June 18, 2014

Report

Report Number: 2531779-2014-17504
Event Type: Malfunction
Date Received: June 18, 2014
Report Date: June 16, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/16/2014 WITH THE FOLLOWING FINDINGS: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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. INVESTIGATION FOUND THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD AND THE THREADS AREA. THE VERIFY SCREEN WAS DIM AND DISCOLORED. THE CONTRAST BUTTON WAS UNRESPONSIVE AND THE BUTTON CONTACT WAS FOUND MISSING. IN ADDITION, CONTAMINATION WAS FOUND UNDER THE ¿OK¿, ¿UP¿ AND ¿DOWN¿ BUTTON CONTACTS. UNRELATED TO THE CASING, DISPLAY AND BUTTON ISSUES, IT WAS OBSERVED THAT THE KEYPAD WAS PEELING AND TORN. NO EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. (B)(6).

Description of Event or Problem · 1

THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED, THE DISPLAY WAS DIM/DISCOLORED AND THE BUTTONS HAD MALFUNCTIONED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/16/2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
358522	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR