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

Device Problem Use of Device Problem (1670)

Patient Problems Dysphasia (2195); Diaphoresis (2452); Cognitive Changes (2551)

Event Type  Injury  

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.

Event Description

On (b)(6) 2017 the reporter contacted animas and alleged that the patient experienced approximate blood glucose (bg) of 30 mg/dl with sweatiness, unable to speak, difficulty speaking and cognitive impairment associated with an inadvertent infusion issue.Reportedly, the patient remained on the insulin pump and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support, (cts) it was noted that the patient was still attached to the pump when it was primed.It was also noted that the reporter was unsure how much unintended insulin the patient received but that the patient¿s normal prime volume is 19 units.This complaint is being reported based on the allegation that the patient experienced hypoglycemia due to use error.

• 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: 6543429
• MDR Text Key: 74372468
• Report Number: 2531779-2017-09395
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406100242
• UDI-Public: 0110840406100242
• 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
• Report Date: 04/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Date Manufacturer Received: 04/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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: 70 YR