FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3771828 · Received April 24, 2014

Report

Report Number: 2531779-2014-11274
Event Type: Malfunction
Date Received: April 24, 2014
Report Date: April 10, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/10/2014 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. DURING TESTING, THE OK AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ENGAGE; ALL OTHER KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL BUTTON CONTACTS. ADDITIONALLY, THE DISPLAY SCREEN TEXT APPEARED DIM, FADED, AND DISCOLORED. THE BATTERY COMPARTMENT WAS ALSO OBSERVED TO BE CRACKED. UNRELATED TO THESE ISSUES, THE KEYPAD COVER WAS FOUND TO BE TORN OFF BELOW THE OK BUTTON, EXPOSING A BUTTON CONTACT, AND A HOLE WAS OBSERVED IN THE BOLUS BUTTON COVER. (B)(6).

Description of Event or Problem · 1

THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A KEYPAD BUTTON RESPONSE ISSUE, CONTAMINATION UNDER KEYPAD BUTTONS, A DISPLAY FAILURE, AND A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04/10/2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
249719	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR