FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3881392 · Received June 18, 2014

Report

Report Number: 2531779-2014-17464
Event Type: Malfunction
Date Received: June 18, 2014
Report Date: June 14, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/01/2014 WITH THE FOLLOWING FINDINGS: A CALL SERVICE ALARM 078-0008 VERIFIED IN THE BLACK BOX AND HISTORY. THERE WAS VISIBLE MOISTURE IN DISPLAY. LEAK TEST FAILED DUE TO CRACKED PUMP CASE. PUMP CASE CRACKED THE TOP RIGHT CORNER BETWEEN THE LENS AND CASE SEAL. POWERED UP PUMP, GOOD AUDIO AND VIBRATORY SOUNDS. THE DISPLAY WAS BLANK. UNABLE TO COMPLETE FAILED STEPS DUE TO BLANK DISPLAY. OPENED PUMP AND REMOVED FROM CASE. MOISTURE AND CORROSION ON DISPLAY FLEX CONNECTOR AND MOTOR FLEX CONNECTOR. 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 FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. 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
357789	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	6 YR