FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3811493 · Received May 15, 2014

Report

Report Number: 2531779-2014-13598
Event Type: Malfunction
Date Received: May 15, 2014
Report Date: May 5, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/05/2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BOLUS BUTTON COVER WAS FOUND TO BE PARTIALLY DETACHED AND THE BOLUS BUTTON WAS UNRESPONSIVE. THE BOLUS BUTTON SLUG WAS OBSERVED TO BE MISSING. UNRELATED TO THE DISPLAY AND BOLUS BUTTON ISSUE, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. (B)(6).

Description of Event or Problem · 1

THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE AND A BOLUS BUTTON ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 05/05/2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
292111	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR