FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 7535822 · Received May 22, 2018

Report

Report Number: 2531779-2018-09493
Event Type: Malfunction
Date Received: May 22, 2018
Report Date: May 14, 2018
Manufacturer: ANIMAS CORPORATION
Product Code: OYC
PMA / PMN Number: P130007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER CAREGIVERS

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

DATE OF SUBMISSION 13-JUN-2018 THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08-JUN-2018 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED UP WITH AUDITORY TONES AND VIBRATIONS TO A BLANK SCREEN. THE REPORTED ¿BLANK SCREEN¿ COMPLAINT WAS DUPLICATED. THE PUMP¿S COVER WAS REMOVED; EEPROM U22 COMPONENT WAS FOUND TO BE CRACKED. THE UNITY TEST CODE DOWNLOADER TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.0.7 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER WORK INSTRUCTIONS 6001112. THE UPLOAD WAS SUCCESSFUL; THE PUMP POWERED UP WITH DISPLAY. THE EEPROM WAS COMMUNICATING PROPERLY; HENCE THE DIAGNOSIS THAT THE FAILURE WAS IN THIS AREA SINCE IT WAS MISSING FROM THE DISPLAY. EEPROM FAILURE WAS CONCLUDED.

Description of Event or Problem · 1

ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN AN INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
376163	ANIMAS VIBE	INSULIN INFUSION PUMP	OYC	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1