FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 3834180 · Received May 27, 2014

Report

Report Number: 2531779-2014-14967
Event Type: Malfunction
Date Received: May 27, 2014
Report Date: May 19, 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.

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: CONFIRMED EVIDENCE OF MOISTURE INGRESS - CORROSION IN BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND A DISPLAY LENS LEAK WAS FOUND. PUMP WAS OPENED TO FURTHER INVESTIGATE FOR INTERNAL MOISTURE DAMAGE. NO EVIDENCE OF MOISTURE DAMAGE WAS FOUND ON INTERNAL COMPONENTS OR PRINTED CIRCUIT BOARDS. MOISTURE DAMAGE FOUND IN BATTERY COMPARTMENT ONLY. UNRELATED TO THE COMPLAINT, OBSERVED THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED. 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 CASING/CONDITION (MOISTURE INGRESS) ISSUE: MOISTURE AND CORROSION IN THE BATTERY COMPARTMENT. 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
310417	ANIMAS VIBE	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1