FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3040936 · Received April 8, 2013

Report

Report Number: 2531779-2013-03779
Event Type: Malfunction
Date Received: April 8, 2013
Report Date: March 14, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 05/16/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE OK AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE; ALL OTHER BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE HARD PRESSES TO ELICIT A RESPONSE. 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
143229	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR