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

Device evaluation: the device has been returned and evaluated by product analysis on 02-oct-2019 with the following findings: the complaint regarding bolus calculation was reported on (b)(6) 2019.According to the pump history the pump was in use until (b)(6) 2019.Due to continued use all bolus and delivery history has been overwritten in review of the available bolus history.The user was using ezcarb feature.According to the bolus history the last 10 ezcarb bolus deliveries calculated correctly.Investigation tested ezcarb calculation using the customers i; c ratio and ifs.Bolus feature is calculating correctly.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.This complaint was previously included in the voluntary summary report submission (vmsr) and is now being submitted as an initial report with investigation findings due to the transition of the vmsr program.

Event Description

On (b)(6) 2019, the reporter contacted animas alleging a history/settings issue.There was no indication that the product caused or contributed to an adverse event.  this issue 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.

• 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: 9248287
• MDR Text Key: 171979550
• Report Number: 2531779-2019-05892
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 135