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

Medical Device Problem Code	Inaccurate Delivery (2339)
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 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.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a history/settings (inaccurate delivery) issue.The reporter alleged the patient experienced a non-specific high blood glucose level, without any symptoms of hyperglycemia.This incident does not meet animas's definition of an adverse event.Customer support has made several attempts to contact the reporter in follow up; however, the reporter did not respond.No further information was available; if further information is provided a follow up report shall be made.This complaint is being reported because there is an allegation against the delivery function of the pump.
Additional Manufacturer Narrative
Follow-up #1: date of submission (b)(6) 2018; device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2018 with the following findings: a review of the pump history showed the daily insulin delivery totals correctly reflected the user's programmed basal rates.During investigation, the pump emitted a call service alarm and prevented further testing.

• 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: 7386425
• Report Number: 2531779-2018-06572
• Device Sequence Number: 13743242
• Product Code: OYC
• UDI-Device Identifier: 10840406100013
• UDI-Public: 10840406100013
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 03/27/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 30 MO
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR