FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3791461 · Received May 5, 2014

Report

Report Number: 2531779-2014-12524
Event Type: Malfunction
Date Received: May 5, 2014
Report Date: April 23, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

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.

Additional Manufacturer Narrative · 1

(B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP HISTORY REVEALED SEVERAL CS 054-0001 CALL SERVICE ALARMS. NO ALARMS WERE DUPLICATED DURING TESTING. THE PUMP CASE WAS REMOVED AND NO DEFECTS WERE FOUND.

Additional Manufacturer Narrative · 1

(B)(4)-CORRECTION: DATE OF SUBMISSION SHOULD READ (B)(4) 2014.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THE REPORTER STATED THAT THE PUMP EMITTED A CS 054 CALL SERVICE ALARM THREE TIMES IN THIRTY DAYS. 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
266775	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR