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

Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	Hyperglycemia (1905)
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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had been hospitalized in 2017.The reporter stated that the patient had slipped into a coma and was hospitalized for several days.The reporter did not provide a specific blood glucose amount but stated that the patient had diabetic ketoacidosis.The reporter was unable to troubleshoot the pump at the time of the call.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event while on the pump.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07-mar-2019 with the following findings:.During investigation, according to the pump history the pump was in use until (b)(6)2019 therefore all history has been overwritten for time of hospitalization.The pump passed all required testing.The basal history matches the total daily dose and basal program.Unrelated to the original complaint, the battery compartment was observed to be cracked.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; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7591458
• Report Number: 2531779-2018-10765
• Device Sequence Number: 209843
• Product Code: OYC
• UDI-Device Identifier: 10840406100181
• UDI-Public: 10840406100181
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 06/06/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 03/13/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 155