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

Device Problem Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Visual Disturbances (2140); Diaphoresis (2452)

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) 2017 alleging that on (b)(6) 2017, the patient experienced hypoglycemia while on insulin pump therapy with blood glucose measuring 1.7 mmol/l with diaphoresis, blurred vision and face being pale.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The patient reportedly self-treated for the blood glucose excursion.The reporter alleged an inaccurate delivery issue with the pump; however, the reporter declined to participate in all of the troubleshooting activities for determination of pump functionality.Animas customer support was able to determine that the basal history matched the active basal program setting and the time and date were set correctly.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with an inaccurate delivery issue.

Manufacturer Narrative

Follow up # 2 date of submission 25-jan-2018 ¿ correction to additional manufacturer narrative.The correct date of submission for follow-up # 1 is 25-jan-2018 and the correct date of evaluation by product analysis is 04-jan-2018.

Manufacturer Narrative

Follow-up # 1 date of submission 17-jan-2018.Device evaluation: the device has been returned and evaluated by product analysis on 22-dec-2017 with the following findings: a review of the pump histories showed no activity outside of normal use; the pump was functioning properly.The total daily dose history indicated that the insulin delivery totals correctly reflected the programmed basal rate targets.The pump¿s ¿ez-prime¿ steps were performed correctly.The pump correctly reflected 48 units after 24 hours on a 2 unit/hour duration test.The pump passed a delivery accuracy test and was found to be operating within required specification and delivery accurately.No defects were found on investigation therefore the investigation was unable to duplicate the initial ¿inaccurate delivery¿ complaint.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: 7047703
• MDR Text Key: 92586586
• Report Number: 2531779-2017-26874
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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: 12/27/2017
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 14 YR