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

Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Type of Reportable Event	Serious Injury
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.No conclusions can be made at this time.
Event or Problem Description
The reporter contacted animas on (b)(6) 2018 alleging the patient experienced hypoglycemia while on insulin pump therapy evidenced by blood glucose measuring 48 mg/dl with confusion and lightheadedness.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The reporter alleged a history/settings issue with the pump; the basal history reportedly does not match the active basal program.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with a history/settings issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 25-mar-2019 with the following findings: a review of the black box showed manual time changes occurred.The daily insulin delivery totals appeared inconsistent due to the time/date changes.The pump passed delivery accuracy testing and was found to be delivering within the required specifications.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 LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8070521
• Report Number: 2531779-2018-19675
• Device Sequence Number: 1593272
• Product Code: OYC
• UDI-Device Identifier: 10840406100082
• UDI-Public: 10840406100082
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/19/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 39 MO
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR