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

Device Problem Electromagnetic Interference (1194)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas for evaluation.An evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.(b)(4).

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging that the patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring >250 mg/dl and extreme drowsiness.The reporter stated the adjustments had been made to the basal rate and the bolus settings of the pump.Additionally, the pump was exposed to extreme environmental conditions; the pump experienced x-ray exposure.The owner's booklet instructs the user to not expose the pump to very strong electromagnetic fields because those strong magnetic fields can re-magnetize the portion of the motor that regulates insulin delivery.The user is advised to remove the pump and keep it outside of the x-ray room unless a lead apron that completely covers the pump is worn during the procedure.This complaint is being reported because the patient reportedly experienced a serious injury while on insulin pump therapy related to an environmental exposure issue.

Manufacturer Narrative

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.Device evaluation: the device has been returned and evaluated by product analysis on 07/21/2016 with the following findings: review of the black box data revealed the last basal delivery and the last bolus delivery were on (b)(6) 2016.On investigation, the pump powers on to the verify screen with vibratory and audible features as per normal operation.An ez-prime sequence and 24 hour duration test were successfully completed.The daily insulin delivery totals correctly reflect user's programmed basal rates.The pump passed delivery accuracy test and was found to be delivering within required range and delivering accurately.Patient negligence issue - pump subjected to conditions outside specifications.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 5785490
• MDR Text Key: 50009753
• Report Number: 2531779-2016-15607
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610021121371122316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Date Manufacturer Received: 06/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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 Age: 23 YR