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

Device Problem Pumping Problem (3016)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The device 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) 2018, the reporter contacted animas and alleged the patient experienced a blood glucose of 63mg/dl, with unsteadiness when standing and walking, and severe dizziness, associated with an alleged inaccurate delivery issue.Reportedly, the patient remained on the pump, and self-treated with food and/or drink.During troubleshooting with customer technical support, it was revealed the basal delivery totals in total daily dose matched the active basal program total.The basal history matched the active basal program settings.The bolus totals did not match.This complaint is being reported based on the allegation that the patient experienced hypoglycemia associated with an inaccurate delivery issue.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 17-dec-2018 with the following findings: during investigation, the complaint regarding iob not calculating correctly was not duplicated.Investigation delivered two 10 unit boluses , iob totaled 20 units.The ez bg results calculated and iob of -20.4.The pump passed all required testing.Testing was unable to duplicate or verify complaints.The complaint regarding bolus deliveries are not adding up with tdd was not duplicated or verified.Bolus totals from (b)(6)/2018 to end of use were reviewed and added up accurately with total daily dose.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.

• 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: 8057783
• MDR Text Key: 126885906
• Report Number: 2531779-2018-19452
• 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,Followup
• Report Date: 10/27/2018

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/27/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 10/27/2018
• Supplement Dates FDA Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR