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

Device Problem Device Issue (2379)

Patient Problem Death (1802)

Event Type  Death  

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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.(b)(6).

Event Description

The reporter contacted animas on (b)(6) 2018 alleging a patient on insulin pump therapy died on (b)(6) at 11:30 am.On (b)(6) 2018, the patient was reportedly hospitalized in a geriatric ward; the patient was reported to have ¿polypathology¿ (multiple chronic diseases), however, no specific detail of the polypathology or hospitalization were provided.On (b)(6) 2018 at 8:00 pm, it was reported that the patient called for assistance and a state graduate nurse changed the patient¿s infusion set and cartridge because the patient was unable to do it themselves.On (b)(6) 2018 at 9:14 pm, the patient called again for assistance with the insulin pump; the patient was reportedly unable to re-start the insulin pump.The state graduate nurse reportedly recalled and explained that the patient was attempting to insert an empty insulin cartridge into the pump.The state graduate nurse committed to checking and controlling the patient¿s blood glucose levels during that night.On (b)(6) 2018 at 11:30 am, the patient reportedly went into a hypoglycemic coma with a blood glucose level of 22 mg/dl and subsequently died.No direct allegation of pump malfunction or defect was alleged by the reporter.No further details of the event were available.The insulin pump is planned to be returned to the manufacturer and an investigation of the product completed per animas procedure.Investigation results will be reported on completion of the investigation.

Manufacturer Narrative

Follow-up #1: date of submission 21-jun-2018 additional information received by animas: on 12-jun-2018, the reporter from hospital group (b)(6) stated that the patient died at 1:10 pm due to complication of the hypoglycemic coma.The reporter noted that the patient¿s blood glucose had been checked three times on (b)(6) 2018 without any hypoglycemia noted.The reporter stated that the patient had supposedly made several reports to the home care company of issues with the pump the week prior this event.The reporter said that also on (b)(6) 2018, the patient changed the insulin cartridge and made the pump settings.The patient was ¿checked on at 10:00 pm that night by the ide and the internal guard and was provided control without particular remarks.¿ on (b)(6) 2018 at 7:00 am, the patient was reportedly found in a hypoglycemic coma with a blood glucose level of 22 mg/dl.Of note, the reporter from the hospital stated that the patient had been independent with insulin pump therapy for 10 years.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 19-jun-2018 with the following findings: black box data revealed that basal deliveries were interrupted on (b)(6) 2018 at 8:00 pm due to an empty cartridge warning.The warning was confirmed by the user at 8:05 pm on (b)(6) 2018.The rewind and load steps were recorded on (b)(6) 2018 at 8:04 pm and 8:24 pm both load steps were followed by the no cartridge detected warning confirming the user installed an empty cartridge as stated by the reporter.On (b)(6) 2018 at 10:17 pm a successful rewind, load, and prime were completed.Basal deliveries were resumed at 10:22 pm on (b)(6) 2018.The pump continued to deliver the programmed basal rate until the pump was manually placed into suspend mode at 7:41 am on (b)(6) 2018.No boluses were programmed and delivered during this time.The total daily dose was within normal expectations prior to the patient¿s death (see below).The pump passed delivery accuracy tests.Unrelated to pump functionality, it was observed that the display screen was pink and dim but readable.Total daily doses on (b)(6) 2018: total units: 6.8850 basal units: 6.8850 bolus units: 0.0 temp basal: no.Suspend: yes.On (b)(6) 2018: total units: 24.750 basal units: 24.750 bolus units: 0.0 temp basal: no.Suspend: yes.16-may-2018: total units: 32.115 basal units: 26.115 bolus units: 6.0 temp basal: no.Suspend: no.15-may-2018: total units: 32.550 basal units: 28.000 bolus units: 4.55 temp basal: no.Suspend no 14-may-2018 total units: 28.000 basal units: 28.000 bolus units: 0.0 temp basal: no.Suspend: no.Conclusion: the basal and bolus insulin doses were delivered as expected.No excess insulin delivery was detected in the black box or the pump history.The only possibilities of excess insulin delivery was if the patient was attached to the infusion set during the prime step or if there was a manual injection of insulin.The patient is warned multiple times about not priming while attached: during training, in the user¿s guide, and on the pump display screens during the rewind, load, and prime steps.Every precaution is taken to ensure that the patient does not prime while attached.

• 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: 7565993
• MDR Text Key: 109949466
• Report Number: 2531779-2018-10210
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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: 06/15/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 41 MO
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• 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): Death