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

Device Problem Use of Device Problem (1670)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Lethargy (2560)

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.(b)(4).

Event Description

On (b)(6) 2019, the reported contacted animas alleging that the patient experienced a blood glucose of 40 mg/dl with unsteadiness when standing or walking, tiredness, adrenaline increase, and sweats associated with an alleged inaccurate delivery issue.Reportedly, the patient discontinued pump therapy and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support, it was noted that the basal delivery totals in the total daily dose did not match due to a suspend and the customer making changes to the basal program.The basal history matched the active basal program settings.This complaint is being reported because the patient experienced hypoglycemia associated with user error.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: kristen lopolito ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 8259515
• MDR Text Key: 133519579
• Report Number: 2531779-2019-00507
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 39 YR
• Patient Weight: 181