FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 6419789 · Received March 20, 2017

Report

Report Number: 2531779-2017-05954
Event Type: Malfunction
Date Received: March 20, 2017
Report Date: February 24, 2017
Manufacturer: ANIMAS CORPORATION
Product Code: OYC
PMA / PMN Number: P130007
Product Problem: Yes
Report Source: Manufacturer report
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. (B)(6).

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/14/2017 WITH THE FOLLOWING FINDINGS:. BLACK BOX SHOWS NO UNUSUAL VOLTAGE FLUCTUATION , "CS162" WARNING WAS UNCONFIRMED FOR 6 HR AFTER POWER UP ON (B)(6) 2017 . BATTERY COMPARTMENT AND CAP ARE UNDAMAGED AND ABLE TO FIT SECURELY..2-¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY, ALL CURRENT READING ARE WITHIN SPECIFICATION NO OVERHEATING OCCURRED DURING THE INVESTIGATION , UNABLE TO DUPLICATE ¿TEMPERATURE¿ COMPLAINT. PUMP¿S COVER WAS REMOVED; NO INTERMITTENT CONDITION WAS FOUND TO CIRCUIT BOARD.

Additional Manufacturer Narrative · 1

EVAL CODE CONCLUSIONS WERE CORRECTED.

Description of Event or Problem · 1

ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. CUSTOMER USING LITHIUM BATTERY WHICH IS 3 WEEKS OLD. BOTH THE BATTERY AND PUMP WERE VERY HOT TO THE TOUCH. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS THE POTENTIAL FOR THE USER TO EXPERIENCE AN INJURY TO THE SKIN DUE TO INCREASED PUMP TEMPERATURE. 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
199487	ANIMAS VIBE	INSULIN INFUSION PUMP	OYC	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1