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

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has not been returned to animas for evaluation.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, alleging a history/settings issue.It was reported that the basal delivery totals in the total daily dose record do not match the active basal program total.The patient¿s blood glucose (bg) was reported to be greater than 250 mg/dl but less than 500 mg/dl with no reported additional signs or symptoms, which does not meet the animas criteria for an adverse event.Rewind sequence.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 30-jan-2019 with the following findings: a review of the black box showed the user switch the active basal programs frequently resulting in inconsistent total daily dose totals.The daily insulin delivery totals correctly reflected the user's programmed basal rates.The basal program recorded accurately in total daily dose during testing.

• 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: 8207301
• MDR Text Key: 131764419
• Report Number: 2531779-2018-21025
• 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: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• 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: 01/09/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 120