FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 6248113 · Received January 12, 2017

Report

Report Number: 2531779-2017-01069
Event Type: Malfunction
Date Received: January 12, 2017
Report Date: December 19, 2016
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

FOLLOW-UP #1: DATE OF SUBMISSION 03/09/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/15/2017 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX REVEALED CS 78-0008 DURING REWIND. ON INVESTIGATION, THE PUMP WAS RUN FOR A MINIMUM OF 24 HOURS WITH NO CS 078-0008 DUPLICATED. ON VISUAL INSPECTION, THERE WAS EVIDENCE OF MOISTURE BEHIND DISPLAY LENS. LEAK TESTING FAILED DUE TO A CASE CRACK WITH LEAK; THERE WAS A CRACK BETWEEN CASE SEAL AND THE KEYPAD COVER. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE ON MAIN PRINTED CIRCUIT/TRANSCEIVER BOARD. UNRELATED TO THE ORIGINAL COMPLAINT, A HAIRLINE BATTERY COMPARTMENT CRACK WAS FOUND BELOW THE BUMPER.

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).

Description of Event or Problem · 1

ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP EMITTED A CS 078 CALL SERVICE ALARM THREE TIMES IN THIRTY DAYS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
31406	ANIMAS VIBE	INSULIN INFUSION PUMP	OYC	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1