FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3973640 · Received August 1, 2014

Report

Report Number: 2531779-2014-22137
Event Type: Malfunction
Date Received: August 1, 2014
Report Date: July 18, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 10/16/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON COVER AND PLUG WERE OBSERVED TO BE DETACHED FROM THE PUMP, EXPOSING THE INTERNAL COMPONENTS. ADDITIONALLY, THE KEYPAD COVER WAS TORN OVER THE UP ARROW BUTTON, EXPOSING THE BUTTON CONTACT. ALL KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION OR OTHER ANOMALIES WERE FOUND AMONG THE BUTTON CONTACTS.

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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
449817	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1