MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas at the time of this report.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.
Event or Problem Description
On (b)(6) 2016, a reporter contacted animas alleging that there were loss of prime warnings with the pump.The reporter stated that the patient had a blood glucose of 250 mg/dl with symptoms of nausea.The alleged blood glucose excursion does not meet criteria for a serious injury.The reporter stated that there had been multiple loss of prime warnings with the pump, causing a delay in insulin delivery.The reporter was able to prime the pump without alarms after changing the cartridge.This complaint is being reported because the patient experienced multiple alarms with their pump.
Additional Manufacturer Narrative
Follow-up # 1 date of submission 1/20/2017.Device evaluation: the device has been returned and evaluated by product analysis on 1/04/2017 with the following findings: there were loss of prime alarm warnings observed in the black box history associated with low non-zero force.The pump was exercised for 24 hours and the loss of prime issue was not duplicated.The force sensor calibration passed within specification.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6181080
• Report Number: 2531779-2016-33931
• Device Sequence Number: 19064833
• Product Code: OYC
• UDI-Device Identifier: 10840406100310
• UDI-Public: 0110840406100310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 48