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

Device Problem Device Issue (2379)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas alleging the patient¿s blood glucose on an unknown date was 300 mg/dl with extreme thirst, nausea, and symptoms of dehydration.The reporter noted the patient did not receive any treatment above and beyond the usual routine of diabetes care and management, they remained on pump therapy, and the pump¿s basal settings were recently changed by a healthcare professional.During troubleshooting, it was reported that: the pump¿s basal history and total daily dose basal history were appropriate for the programmed basal rates; the bolus history matched the total daily dose bolus history; the pump was calculating recommended bolus totals correctly; the pump successfully delivered an air bolus, which was correctly recorded in the bolus history.After troubleshooting, an allegation remained that there were missing bolus records in the bolus history.This complaint is being reported because the reported health event was attributed to an alleged pump malfunction.

Manufacturer Narrative

Follow-up #1: date of submission 09/20/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/24/2016 with the following findings: a review of the bolus history showed that no boluses were programmed or delivery on (b)(6) 2016.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.The pump successfully completed a rewind, load, and prime sequence.The pump was exercised for 24 hours with no errors, alarms, or warnings occurring.The pump passed delivery accuracy testing and was found to be delivering within required specifications.A 10unit normal bolus and a 10unit audio bolus were successfully performed and both were accurately recorded in the pump history.The bolus history was found to be recording properly.The keypad buttons were tested and no hypersensitivity was found.The complaint could not be confirmed or duplicated on investigation.Unrelated to the original complaint, investigation revealed that the battery compartment was 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
• 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: 5883230
• MDR Text Key: 52339236
• Report Number: 2531779-2016-21477
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100068
• UDI-Public: 0110840406100068
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• 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: 08/13/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• 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
• Patient Age: 37 YR