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

Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Hypoglycemia (1912); Blurred Vision (2137)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas.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 that the patient experienced a blood glucose (bg) of 36 with blurred vision associated with an alleged inaccurate delivery issue.Reportedly, the patient remained on the pump and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support, it was reported that the health care provider (hcp) made adjustment to bg.Patient hcp has increased bg since 11/18/2018 the reporter stated that the bg was increased due to rebounded bg of 400mg/dl.Patient stated treatment of low bg consisted of consuming carbs.Patient also stated in the past hcp tried making adjustment to pump and got very frustrated.Patient refused to complete troubleshooting due to blurred vision caused by low bg.Patient was advised to discontinue use of pump.Patient refused to contact hcp concerning alternate form of insulin delivery.It was reported that the basal history matched the active basal program settings.This complaint is being reported based on the allegation that the patient experienced issues with their blood glucose.The pump could not be ruled out as a contributing factor.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07-mar-2019 with the following findings: a review of the basal record history and total daily dose showed the pump delivered the programmed basal rate.The basal records and total daily dose matched.The pump passed all required delivery accuracy testing.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: 8132464
• Report Number: 2531779-2018-20304
• Device Sequence Number: 1233992
• Product Code: OYC
• UDI-Device Identifier: 10840406100068
• UDI-Public: 10840406100068
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/26/2018

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 40 MO
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 03/11/2019
• 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: 55 YR
• Patient Weight: 210