FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3023597 · Received March 27, 2013

Report

Report Number: 2531779-2013-03150
Event Type: Malfunction
Date Received: March 27, 2013
Report Date: March 21, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 06/05/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: KEYPAD IS FULLY INTACT, WITH NO PEELING OR DAMAGE OBSERVED. ¿DOWN¿ AND ¿OK¿ KEYS RESPOND INTERMITTENTLY. ¿CONTRAST¿ AND ¿UP¿ KEYS RESPOND. KEYPAD WAS REMOVED TO INVESTIGATE, EVIDENCE OF KEYPAD CONTAMINATION WAS LOCATED, UNDER ¿CONTRAST¿,"DOWN" AND "OK" CONTACT BUTTON. 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

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER INDICATED THAT THE BUTTONS WERE STICKING FOR APPROXIMATELY TWO MONTHS. THE REPORTER CONFIRMED THAT THERE WAS NO KNOWN DAMAGE TO THE KEYPAD. 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
126688	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 YR