FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 8378636 · Received February 28, 2019

Report

Report Number: 2531779-2019-01602
Event Type: Malfunction
Date Received: February 28, 2019
Report Date: February 26, 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

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

DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 29-MAY-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THERE WAS A CALL SERVICE 078-0008 ALARMS IN PUMP HISTORY. DURING REWIND A CALL SERVICE 078-0008 ALARM OCCURRED. UNABLE TO PERFORM STEP 18 DUE TO ALARM. THERE WAS MOISTURE VISIBLE IN DISPLAY. THE BATTERY COMPARTMENT IS CRACKED AND LEAKED. THE PUMP WAS OPENED; MOISTURE DAMAGE FOUND ON THE PRINTED CIRCUIT BOARD. DUE TO THE MOISTURE DAMAGE, THE ALARM OCCURRED. 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.

Description of Event or Problem · 1

ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE 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
173133	ANIMAS VIBE	INSULIN INFUSION PUMP	OYC	ANIMAS LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1