FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2972330 · Received February 21, 2013

Report

Report Number: 2531779-2013-02000
Event Type: Malfunction
Date Received: February 21, 2013
Date of Event: July 27, 2012
Report Date: July 6, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(6). RECALL#: 2531779-03/24/2010/003-R. THE PUMP WAS RETURNED TO ANIMAS FOR A CRACKED CASE, MOISTURE IN THE PUMP, AND LARGE PRIME VOLUME. DURING INVESTIGATION, THE REWIND, LOAD, AND PRIME STEPS WERE COMPLETED WITHOUT DIFFICULTY OR ALARM. OCCLUSION ALARMS AND A LARGE PRIME VOLUME WERE VERIFIED IN THE BLACK BOX. PUMP WAS EXERCISED FOR 24HRS AT 1U PER HR BASAL RATE WITH NO ALARMS. THE FORCE SENSOR READING WAS FOUND TO BE OUT OF SPECIFICATION. THE PUMP WAS REMOVED FROM THE CASE, AND MOISTURE AND CORROSION WAS OBSERVED ON ALL INTERNAL PARTS INCLUDING THE FORCE SENSOR PLATE. THE FORCE SENSOR PLATE WAS REMOVED AND MOISTURE WAS SEEN INSIDE OF THE FORCE SENSOR. WHEN THE FORCE SENSOR RESISTANCE WAS MEASURED, IT READ HIGH AT 10.3K OHMS. UNRELATED TO THE REPORTABLE MALFUNCTION, THE PUMP WAS FOUND TO HAVE A SCRATCHED DISPLAY LENS, A FADED KEYPAD, AND PEELING PAINT.

Description of Event or Problem · 1

THE PUMP WAS RETURNED AND EVALUATED BY ANIMAS ON (B)(6) 2012. WHEN THE PUMP WAS TESTED, A FORCE SENSOR DEFECT WAS DISCOVERED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BASED ON INVESTIGATION RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
77187	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ONETOUCH PING INSULIN PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 YR