FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 8777750 · Received July 10, 2019

Report

Report Number: 2531779-2019-04012
Event Type: Malfunction
Date Received: July 10, 2019
Report Date: July 2, 2019
Manufacturer: ANIMAS LLC
Product Code: OYC
PMA / PMN Number: P130007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

CORRECTION: CUSTOMER TECHNICAL SUPPORT HAS DETERMINED THE DEVICE TO BE A VIBE INSULIN PUMP. THE CORRECT PUMP INFORMATION IS AS FOLLOWS: SERIAL #: (B)(4), BRAND NAME: ANIMAS VIBE, MODEL #: ANIMAS VIBE INSULIN PUMP, PMA/510(K)#: P130007.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 13-SEP-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON AND THE DISPLAY WAS FOUND TO BE DIM AND FADING. 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.

Additional Manufacturer Narrative · 1

THE DEVICE 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.

Description of Event or Problem · 1

ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE FOR AN UNKNOWN PUMP. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL OF THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
572409	ANIMAS VIBE	INSULIN INFUSION PUMP	OYC	ANIMAS LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1