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

Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905); Polydipsia (2604)
Type of Reportable Event	Serious Injury
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 of 452 mg/dl with polydipsia and symptoms of dehydration associated with an alleged unusual 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, the reporter stated that they thought there was a loss of prime alarm that went off but it was not indicated on the screen.The reporter stated that this issue was an intermittent issue.Upon further troubleshooting, there were no alarms indicated in the alarm history and the loss of prime alarm could not be certain.The reporter stated that because of this issue, the patient¿s bg went up.This complaint is being reported because the patient experienced hyperglycemia due to an unknown alarm.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 30-jan-2019 with the following findings: a review of the black box showed no evidence of delivery malfunctions.According to the total daily dose totals from the date of the complaint until the end of use, the daily total daily dose added up correctly with the basal program.The black box data was unavailable due to continuous use of the pump.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: 8183955
• Report Number: 2531779-2018-20802
• Device Sequence Number: 11199418
• Product Code: OYC
• UDI-Device Identifier: 10840406100228
• UDI-Public: 10840406100228
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 12/13/2018

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: 01/26/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 23 MO
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/04/2019
• 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: 67 YR