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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
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 (damage) issue.The reporter alleged an intermittent power issue with a crack in the battery compartment and the battery cap not securing properly to the pump.The reporter denied damage to the battery cap and stated the cap had never been replaced.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
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.Device evaluation: the device has been returned and evaluated by product analysis on 06-nov-2018 with the following findings: on investigation, the alleged cracked battery compartment was confirmed.The returned battery cap had stripped threads and was unable to secure properly to the pump.With the test cap on the pump, the pump was not able to power on.The power issue was duplicated when attempting to use the damaged battery cap that was returned with the pump.A test battery cap was placed on the pump and was able to fit securely.With the test battery cap in place on the pump, the pump powered on normally and was exercised for 12 hours without any interruption in power.There was no damage, defect or contamination of the pump¿s interior components.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7973577
• Report Number: 2531779-2018-18359
• Device Sequence Number: 11205971
• Product Code: OYC
• UDI-Device Identifier: 10840406103106
• UDI-Public: 10840406103106
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 10/01/2018

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: 10/31/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 203