FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2874136 · Received December 14, 2012

Report

Report Number: 2531779-2012-14578
Event Type: Malfunction
Date Received: December 14, 2012
Report Date: November 20, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO DAMAGE WAS OBSERVED. THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. THE DOWN ARROW AND OK BUTTONS RESPONDED APPROPRIATELY. THE ORIGINAL COMPLAINT OF THE OK BUTTON'S HYPER-SENSITIVITY WAS NOT DUPLICATED. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEYPAD BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM/FADING DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE OK KEYPAD BUTTON WAS AT TIMES HYPER-RESPONSIVE AND INTERMITTENTLY UNRESPONSIVE. 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
1	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ONETOUCH PING INSULIN PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR