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

Medical Device Problem Code	Pumping Problem (3016)
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 (history/settings issue) issue.The reporter alleged the pump bolus history shows deliveries that the patient knows they did not make on (b)(6) 2018, (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018.The reporter stated that the patient experienced hypoglycemia in early august with blood glucose measuring 44 mg/dl with arm weakness.This combination of blood glucose level and symptom does not meet animas' criteria for a reportable adverse event.No adverse event is being reported in association with this complaint.The pump's bolus totals do not match what was programmed by a >5% difference.This issue is being reported as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 17-dec-2018 with the following findings: a review of the pump history showed the total daily doses added up correctly and reflected the programmed basal rate target.Unrelated to the original complaint, the cartridge compartment was missing a fragment at the edge.The battery compartment and returned battery cap was undamaged and able to fit.The ¿ez-prime¿ steps were performed correctly.The pump reflected 12 units after a on 1 unit per hour duration test for 12 hours.A 10 unit test bolus was correctly delivered and recorded.The product performed within specifications.The alleged ¿inaccurate delivery¿ issue was unable to be duplicated during investigation.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8043592
• Report Number: 2531779-2018-19151
• Device Sequence Number: 19187750
• Product Code: OYC
• UDI-Device Identifier: 10840406100082
• UDI-Public: 10840406100082
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 37 MO
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR