FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 7319480 · Received March 6, 2018

Report

Report Number: 2531779-2018-04881
Event Type: Malfunction
Date Received: March 6, 2018
Report Date: February 24, 2018
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K032257
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER CAREGIVERS

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP #2: DATE OF SUBMISSION (B)(6) 2018 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED MULTIPLE LOSS OF PRIME WARNINGS WITH A LOW NON ZERO FORCE. THE PUMP WAS RUN FOR 24 HOURS AND NO ALARMS OCCURRED. THE FORCE CALIBRATION TESTING PASSED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TO THE GRIP PAD.

Additional Manufacturer Narrative · 1

FOLLOW UP # 1 DATE OF SUBMISSION 09-MAR-2018: - CORRECTION: ANIMUS VIBE - CORRECTION: ANIMUS VIBE INSULIN PUMP - CORRECTION: PMA/510 (K) #: P130007

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. 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) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE LOSS OF PRIME OCCURRED MULTIPLE TIMES. THERE IS NO INDICATION THAT THE 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
162267	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR