MAUDE Adverse Event Report: ANIMAS CORPORATION 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 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) 2017, the reporter contacted animas, alleging a button/keypad (tactile changes/unresponsive) issue.It was reported that the up arrow, down arrow, and ok/enter buttons were under-responsive.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 10/23/2017 with the following findings: during investigation the original allegation of an under responsive keypad was unable to be duplicated.The keypad was found to be intact with no evidence of peeling or damage, and all keys were responsive.The keypad was removed with no evidence of contamination on the key contacts.Unrelated to the original complaint, the battery compartment was found to be cracked below and above the grip pad.A cover crack was found between the corner of lens and the case seal.A leak test was performed and failed due to a battery compartment leak and the cracked pump case.Moisture was found inside on the display, battery compartment, and on all the printed circuit board.There was evidence of the moisture corrosion on the keypad connector.The battery cap was also found to have stripped threads, and was unable to tighten the battery cap to the test pump, a test cap was used for all steps.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.

• 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: 6805312
• Report Number: 2531779-2017-18687
• Device Sequence Number: 2066404
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 0110840406100358
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/07/2017

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: 09/12/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR