FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 4766132 · Received May 12, 2015

Report

Report Number: 2531779-2015-15749
Event Type: Malfunction
Date Received: May 12, 2015
Report Date: April 28, 2015
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PATIENT

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

FOLLOW-UP #1: DATE OF SUBMISSION 07/02/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/17/2015 WITH THE FOLLOWING FINDINGS: CALL SERVICE 078-0008 ALARMS OBSERVED IN THE BLACK BOX AND ALARM HISTORY. DURING REWIND, A CALL SERVICE 078-0008 ALARM OCCURRED. UNABLE TO PERFORM CHECKLIST STEPS 21 AND 22 DUE TO CALL SERVICE ALARM. THE PUMP WAS OPENED MOISTURE DAMAGE FOUND ON PCB. WHEN A TEST MOTOR WAS CONNECTED TO PUMP A CALL SERVICE 078-0008 WAS DUPLICATED. RECURRING ALARM DUE TO MOISTURE DAMAGE. RETURNED BATTERY CAP USED FOR INVESTIGATION. 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.

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
308973	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR