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

Device Problems Premature Discharge of Battery (1057); Moisture Damage (1405)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Visual Impairment (2138)

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 >400 mg/dl with trace urinary ketones, blurred vision, nausea and dehydration.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The reporter alleged the patient¿s hyperglycemia was associated with issues of battery life being less than expected and moisture in the battery compartment.Troubleshooting by animas customer support confirmed that low battery alarms appeared in the pump¿s alarm history.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with a battery life with moisture 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 25-apr-2018 with the following findings: on examination, there was no moisture or moisture corrosion in the battery compartment as alleged in the initial report.The battery compartment was intact and without damage.Review of the black box data revealed that partially-discharged batteries were installed in the pump on (b)(6) 2018, resulting in ¿replace battery¿ alarms.The total daily doses added up to correctly reflect the user¿s programmed basal rates.The pump was powered on and electrical currents evaluated and found to be within required specifications.The pump was exercised for 24 hours without any delivery defects.There was no damage, defect or contamination of the pump¿ interior components.The pump was found to be delivering as programmed without malfunction.Investigation did not confirm nor duplicate a battery life issue.The user had installed partially discharged batteries in the pump.

• 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: 7360740
• MDR Text Key: 103135414
• Report Number: 2531779-2018-05913
• Device Sequence Number: 1
• Product Code: OYC
• 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
• Report Date: 03/14/2018

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 05/09/2018
• 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): Life Threatening
• Patient Age: 12 YR