FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3870466 · Received June 12, 2014

Report

Report Number: 2531779-2014-16769
Event Type: Malfunction
Date Received: June 12, 2014
Report Date: June 4, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE TORN AT THE UP ARROW BUTTON. ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND UNDER THE UP ARROW AND CONTRAST BUTTON CONTACTS. EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED ON THE THREADS AND BATTERY CAP WAS DAMAGED STRIPPED. EVALUATION ALSO REVEALED A DIM, FADING AND DISCOLORED DISPLAY SCREEN. UNRELATED TO THESE ISSUES, THE AUDIO BOLUS BUTTON COVER WAS TORN BUT THE BUTTON RESPONDED NORMALLY. (B)(6).

Description of Event or Problem · 1

THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED EVIDENCE OF CONTAMINATION UNDER THE UP ARROW AND CONTRAST KEYPAD BUTTON CONTACTS. EVALUATION ALSO REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED ON THE THREADS AND THE BATTERY CAP WAS STRIPPED. IN ADDITION, THE DISPLAY SCREEN WAS DIM, FADING AND DISCOLORED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
348601	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR