MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Device Problem Use of Device Problem (1670)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Cognitive Changes (2551)

Event Type  Injury  

Manufacturer Narrative

The pump is not expected for return.The conclusion is that this complaint was the result of use error (priming while attached).

Event Description

On (b)(6) 2018, it was reported that the patient experienced blood glucose (bg) reading of 48 mg/dl with symptoms of fogginess and sweating.The patient was treated (b)(6) by a family member; emergency services were called but monitored the patient without providing additional treatment.It was reported that there was a communication call service alarm and that the patient primed while attached to the pump in order to clear the alarm.The patient reportedly infused 19.1 units of insulin into the body inadvertently even though there are multiple warnings in the owner's booklet and on the pump screen not to do so.The patient remained on the pump and a replacement pump was determined to not be required.This complaint is being reported because use error led to an adverse event by priming while attached.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• 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: 7205883
• MDR Text Key: 97751394
• Report Number: 2531779-2018-01353
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10840406100976
• UDI-Public: 10840406100976
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 01/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Date Manufacturer Received: 01/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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 Age: 70 YR
• Patient Weight: 178