FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3875130 · Received June 16, 2014

Report

Report Number: 2531779-2014-17150
Event Type: Malfunction
Date Received: June 16, 2014
Report Date: June 12, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, 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 07/25/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/18/2014 WITH THE FOLLOWING FINDINGS: THERE WERE PUMP REBOOTS OBSERVED IN THE BLACK BOX HISTORY. THE BATTERY COMPARTMENT WAS CRACKED. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP, SO A TEST CAP WAS ABLE TO ATTACH TO THE PUMP AND WAS USED TO COMPLETE TESTING. NO POWER INTERRUPTIONS WERE DUPLICATED. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT OBSERVED WHEN THE PUMP COVER WAS REMOVED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN HAD A DISCOLORED CONTRAST. ALSO UNRELATED, THE AUDIO BOLUS BUTTON COVER WAS MISSING.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (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
352233	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR