FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3934526 · Received July 15, 2014

Report

Report Number: 2531779-2014-20051
Event Type: Malfunction
Date Received: July 15, 2014
Report Date: June 24, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/24/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT MULTIPLE LOSS OF PRIME WARNINGS WERE RECORDED AFTER OCCLUSION ALARMS. NO EVIDENCE OF A LOAD STEP MALFUNCTION OCCURRING WAS OBSERVED IN THE BLACK BOX HISTORY. DURING TESTING, THE PUMP PERFORMED THE REWIND, LOAD, AND PRIME STEPS WITH NO ALARMS OCCURRING. THE PUMP CASE WAS REMOVED AND NO INTERMITTENT CONDITION WAS FOUND TO THE FORCE SENSOR CIRCUIT. THE COMPLAINT THAT THE PUMP WAS NOT RECOGNIZING CARTRIDGES WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (PRIME ISSUE) ISSUE. IT WAS ALLEGED THAT THE CARTRIDGE WAS NOT RECOGNIZED. 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
411966	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1