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

Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that the keypad buttons were under responsive.This complaint is being reported because the issue has the ability to result in an inadvertent or incorrect insulin delivery or the inability to use the pump.The reporter did state that the patient had a blood glucose of 273 mg/dl with symptoms of excess urination.The alleged blood glucose excursion does not meet animas criteria for a serious injury.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 04-dec-2018 with the following findings: during investigation, the keypad was found to be intact; no damage or peeling was observed.All keypad buttons were responsive to button presses during testing.The keypad was removed and no evidence of contamination was observed on the button contacts.The pump was opened and no evidence of the moisture corrosion was found near the keypad connector.The complaint of a keypad response issue was not duplicated during investigation.There were no defects found.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8000093
• Report Number: 2531779-2018-18694
• Device Sequence Number: 1311752
• Product Code: OYC
• UDI-Device Identifier: 10840406103106
• UDI-Public: 10840406103106
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• 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): 10/08/2018

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: 10/22/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR