FDA Adverse Event Malfunction Summary report: N

ANIMAS VIBE

MDR report key: 6639328 · Received June 13, 2017

Report

Report Number: 2531779-2017-12378
Event Type: Malfunction
Date Received: June 13, 2017
Report Date: May 22, 2017
Manufacturer: ANIMAS CORPORATION
Product Code: OYC
PMA / PMN Number: P130007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
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

DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/06/2017 WITH THE FOLLOWING FINDINGS: 1-BLACK BOX SHOWS NO EVIDENCE OF SHORT BATTERY LIFE, MULTIPLE ¿CS128-FB80/0088¿ ALARMS ON (B)(6) 2017. BATTERY COMPARTMENT AND CAP ARE UNDAMAGED AND ABLE TO FIT SECURELY. ABB COVER AND SLUG ARE DETACHED AND MISSING. THE 2-¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY, ALL CURRENTS READING ARE WITHIN SPEC, UNABLE TO DUPLICATE ¿SHORT BATTERY LIFE¿ COMPLAINT. PUMP¿S COVER WAS REMOVED, MOISTURE CORROSION WAS FOUND TO THE RTC CIRCUIT. 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) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. 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
419188	ANIMAS VIBE	INSULIN INFUSION PUMP	OYC	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR