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

Device Problem Date/Time-Related Software Problem (2582)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Blurred Vision (2137)

Event Type  Injury  

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 Description

On (b)(6) 2017, the reporter contacted animas and alleged that the patient experienced an elevated blood glucose around 300 mg/dl with abdominal pain, blurred vision, nausea and an upset stomach, symptoms of dehydration (dizzy, lightheaded), dry eyes and an unspecified level of ketones associated with an alleged time/date reset issue.Reportedly, the patient continued pump therapy and received an unspecified treatment by a healthcare provider in a doctor¿s office visit.During troubleshooting with customer technical support (cts), it was revealed that the time and date was correctly maintained when the battery was removed from the pump for less than 12 hours.The patient stated that their medical provider noted that the patient¿s am and pm time in their pump were reversed.The patient also alleged that the year in the pump would change by itself.Troubleshooting concluded that use user error did not cause time/date issue.Once the time and date issue was resolved the patient was able to get their bg under control again.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an alleged time/date reset issue.

Manufacturer Narrative

Describe event or problem: the following information should be added: the patient was treated by a healthcare provider in a doctor¿s office visit on (b)(6) 2017.

Manufacturer Narrative

The device was returned to the manufacturer and investigated by product analysis on 10-jan-2018 with the following findings: black box data from (b)(6) 2017 was not available for review.The available black box data shows a manual suspend on (b)(6) 2018 14:07.The date was then manually changed to (b)(6) 2017 14:27 and deliveries resumed.The total daily dose history goes from (b)(6) 2017.The black box data for theses dates is not available.There were no hypersensitive or stuck keys observed on the keypad.The daily insulin delivery totals correctly reflected the user's programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering within required range and delivering accurately.No errors, alarms or warnings occurred during testing.A timekeeping accuracy test was performed; the pump passed and was able to maintain time/date settings with accuracy.Investigation did not duplicate the complaint.The black box data for the time of the complaint was overwritten.

• 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: 7156292
• MDR Text Key: 96110090
• Report Number: 2531779-2017-29502
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406100198
• UDI-Public: 10840406100198
• 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: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 118