FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3842206 · Received May 31, 2014

Report

Report Number: 2531779-2014-15364
Event Type: Malfunction
Date Received: May 31, 2014
Report Date: May 26, 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 08/05/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/23/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX SHOWED EVIDENCE OF SUDDEN VOLTAGE DROPS ON 05/07/2014. MULTIPLE BATTERY RELATED ALARMS WERE OBSERVED IN THE ALARM HISTORY. DURING TESTING THE PUMP WAS ABLE TO POWER ON AND PRIME CORRECTLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS. THE CURRENT DRAWS WERE FOUND TO BE ABOVE SPECIFICATIONS. AN INTERMITTENT CONNECTION WAS FOUND ON THE PRINTED CIRCUIT BOARD. THE CONNECTION WAS RE-ESTABLISHED AND THE CURRENT DRAWS WERE NORMAL. 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.

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 POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE BATTERY LIFE WAS SHORTER THAN EXPECTED. 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
320535	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1