FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 4852285 · Received June 17, 2015

Report

Report Number: 2531779-2015-20185
Event Type: Malfunction
Date Received: June 17, 2015
Report Date: June 5, 2015
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, 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

FOLLOW-UP #1: DATE OF SUBMISSION 08/18/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/27/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS EVIDENCE OF THREE "POR" EVENTS ON (B)(6) 2015. THE PUMP POWERS WITH RETURNED BATTERY CAP TO A DIM DISCOLORED DISPLAY. BATTERY CAP IS ABLE TO FULLY TIGHTEN. BATTERY COMPARTMENT CRACK OBSERVED BELOW GRIP PAD. EVIDENCE OF MOISTURE CONTAMINATION ON BATTERY CAP CONTACTS AND CONTACT HUB. CURRENT DRAWS WITHIN SPECIFICATIONS. THERE WAS NO EVIDENCE OF EXCESSIVE BATTERY USAGE OR EXCESSIVE PUMP TEMPERATURE DUPLICATED DURING 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 TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) 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
395758	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR