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

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Vomiting (2144); Urinary Frequency (2275); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553); Polydipsia (2604)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

The pump 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 that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose (bg) of 611 mg/dl with rapid/deep breathing, abdominal pain, extreme drowsiness, blurred vision, extreme thirst, excess urination, nausea, vomiting, confusion, and large ketones.The patient reportedly remained on the pump and was treated with intravenous fluids, insulin injection(s), and insulin via the pump.The patient reportedly remained hospitalized at the time of contact with animas.The patient's healthcare provider reportedly adjusted basal rates before or after the alleged bg excursion.Customer technical support reviewed the pump with the reporter and found that the basal delivery totals did not match, however the discrepancy was determined to be due to normal pump use, as the suspend feature, basal edit screen, and prime menu had been accessed.Additionally, it was noted that the basal/temp basal rates had been incorrectly programmed and the patient also was experiencing a change in stress level.All other settings and histories were found to be correct.Although no product defects were found during troubleshooting, the patient reportedly insisted the pump be replaced.This complaint is being reported based on the allegation that the patient experienced hyperglycemia requiring medical intervention associated with an alleged pump malfunction.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 07/05/2016 with the following findings: a review of the pump histories indicated that the pump was manually suspended on 06/09/2016 at 05:32 and manually resumed the same day at 18:07.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 on a 2.0unit per hour basal rate; at the end of the 24 hour testing, the basal history correctly showed 2.0units per hour and the total daily dose history correctly reflected 48.0units.The pump passed delivery accuracy testing and was found to be delivering within required specifications.No delivery interruptions or errors, alarms, or warnings occurred during 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.(b)(4).

• 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: 5747761
• MDR Text Key: 48103022
• Report Number: 2531779-2016-13186
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610005121486739316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR