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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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.(b)(4).
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas and alleged the patient experienced a blood glucose of 50mg/dl, with unsteadiness with standing and walking, and a blood glucose of 350mg/dl, with nausea, 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 revealed the basal delivery totals in total daily dose did not match due to an accessed basal edit, and prime menu.Changes were also made to the pump basal program.The basal history matched the active basal program settings.The bolus totals matched, and all boluses were recorded as programmed.The patient alleged the pump was not delivering as it was supposed to.This complaint is being reported based on the allegation that the patient experienced hyperglycemia and hypoglycemia associated with use error of the pump.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8258433
• Report Number: 2531779-2019-00505
• Device Sequence Number: 13962075
• Product Code: OYC
• UDI-Device Identifier: 10840406100242
• UDI-Public: 10840406100242
• 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
• Report Date (Section B): 01/15/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/17/2019
• 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: 50 YR
• Patient Weight: 158