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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
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 power (no power) issue.The reporter alleged the pump had no power.The reporter denied damage to the pump, damage to the battery cap and denied moisture in the pump.The reporter denied the yellow o-ring on the battery cap was visible when secured to the pump.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 21-dec-2018 with the following findings: a review of the pump black box showed an unexplained pump reboots on 21-nov-2018.A visual inspection of the pump revealed the battery compartment was cracked; the returned battery cap was undamaged.There was no evidence of moisture contamination inside the battery compartment.The returned battery cap was able to fit securely to maintain an electrical connection.The pump powered on with audible tones and vibrations indicating that there was power to the pump.The pump was exercised for 12 hours with no power interruptions occurring.The complaint of no power was shown in the pump history but was not duplicated during investigation.Unrelated the complaint, the pump¿s cover was removed and moisture corrosion was observed to the power printed circuit board.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8115912
• Report Number: 2531779-2018-20163
• Device Sequence Number: 1527911
• Product Code: OYC
• UDI-Device Identifier: 10840406100327
• UDI-Public: 10840406100327
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 11/27/2018

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: 12/18/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/31/2018
• 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: 56