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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 09/17/2015

Event Type  Death  

Manufacturer Narrative

The pump 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)(6).

Event Description

On (b)(6) 2015, the reporter contacted animas alleging on the morning of (b)(6) 2015, the reporter found the patient dead at home.There was no indication of cause of death.The following sequence events reportedly occurred on (b)(6) 2015: the reporter viewed the pump and noticed at 8:11pm, the continued glucose monitor (cgm) provided a blood glucose (bg) measurement, at 8:22pm the pump emitted a "low " bg alarm and then the patient administered a "16e" bolus.It was not indicated what "16e" meant and there were no bg values or symptoms provided.There was no indication as to whether or not the patient bolused via the pump or used another method.There was also no indication as to reason(s) why the patient bolused after the pump emitted a "low bg" alarm or whether or not the patient may have over bolused using the pump or used another method to bolus.It was noted that the reporter wanted to know if the pump had been delivering basal since there was reportedly no battery inserted in the pump.No additional information was provided regarding this complaint.Animas has requested the return of the device and as of (b)(6) 2015, the pump has not been returned.Animas customer technical support has made multiple attempts to follow up with the reporter to obtain additional information regarding this complaint and has been unsuccessful.If animas receives additional information on this complaint a follow to this report will be submitted.This complaint is being reported because it is unclear as to the cause of the patient's death, if there may have been use error and if the pump was involved, if there was a pump malfunction and/or if the pump may have been a contributing factor to the reported death.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

The pump has not been returned to animas for evaluation.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.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.On (b)(6) 2015, animas received additional information regarding this complaint.The reporter indicated that the family has declined the return of pump to the manufacturer for investigation and that they will give the pump to the hospital to be solely used for demo-purposes only.No additional information was received regarding this complaint.

• 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: 5123125
• MDR Text Key: 27303134
• Report Number: 2531779-2015-35534
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2015
• 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): Death