FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 4572982 · Received March 5, 2015

Report

Report Number: 2531779-2015-07543
Event Type: Malfunction
Date Received: March 5, 2015
Report Date: February 19, 2015
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

FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/07/2015 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE CAP AND BATTERY CAP WAS NOT RETURNED; THEREFORE A TEST BATTERY CAP WAS USED TO VERIFY STEPS. A REVIEW OF THE BLACK BOX REVEALED EVIDENCE OF CALL SERVICE (CS) 078-0008 ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS AND THERE WERE NO CS 078-0008 ALARMS DUPLICATED DURING TESTINGS. THE PUMP CASE WAS REMOVED; THERE WERE NO DEFECTS FOUND TO THE PCB. 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) 2015, 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
155164	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 YR