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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144)
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 reported contacted animas alleging that the patient experienced a blood glucose of 600 mg/dl with vomiting associated with an alleged power 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.The patient did administer insulin via injection.During troubleshooting with customer technical support, it was noted that the pump was beeping with a blank display.The patient changed the battery once and it continued, the patient then changed the battery while on the call to cts and the pump powered on and the history showed a replace battery alarm.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7685017
• Report Number: 2531779-2018-12851
• Device Sequence Number: 1397933
• Product Code: OYC
• UDI-Device Identifier: 10840406100310
• UDI-Public: 10840406100310
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/13/2018
• 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: 13 YR
• Patient Weight: 50