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

Device Problem Device Issue (2379)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Lethargy (2560)

Event Type  Injury  

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.No conclusions can be made at this time.

Event Description

The reporter contacted animas on (b)(6) 2018 alleging the patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring 19 mmol/l, moderate urinary ketones, abdominal pain, lethargy and dehydration.Emergency medical services was called and the patient was reportedly hospitalized and received treatment in the form of insulin via injection and intravenous fluids.The patient had discontinued insulin pump therapy and remained hospitalized at the time the incident was reported to animas.The reporter alleged after checking the basal programs and basal history there were two wrong segments for the morning hours.The basal setting for 10:00 am is 0.5 unit and 11:00 am is 0.375 units.During troubleshooting by animas customer support, the basal history records found in the history for 10:25 am as 0.0 unit and 11:13 am as 0.0 unit.Anima customer support reviewed with the pump with the patient and there were no unconfirmed alarms and no battery or cartridge changes.The pump was not suspended and had not received loss of prime warning.The basal and prime menus had not been accessed.After troubleshooting the pump, animas customer support found no reason for 0 unit records in the basal history.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with a history/settings issue.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 17-sep-2018 with the following findings: a review of the black box showed the last delivered bolus was a 2.00 unit normal bolus.The basal history appeared to be inaccurate due to a rewind, load, and prime sequence related to a cartridge change and the pump being manually suspended and manually resumed.The total daily doses added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.The pump was exercised for 12 hours with a 2.0 unit per hour basal rate.At the end of testing the basal history correctly showed 2.0 units and the total daily dose showed 24.0 units.The alleged basal history recording defect was unable to be duplicated during 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
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7628050
• MDR Text Key: 111976432
• Report Number: 2531779-2018-11546
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 9 YR