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

Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a history/settings (history/settings issue) issue.The reporter alleged the basal programs were missing from the pump.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because it may result in over or under delivery due to running the incorrect time segment.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 01-may-2018 with the following findings: during the investigation, a review of the black box showed a blank basal program manually activated on 14-apr-2018 at 09:14 followed by a basal edit not saved error at 09:42; indicating the user attempted to edit the basal rate but did not select save.The pump was exercised for 24 hours with a 1.0 unit per hour basal rate.At the end of the testing the basal history correctly showed 1.0 unit and the tdd showed 24.0 units.No change to the basal program occurred during testing.No hypersensitive or stuck keys were observed on the keypad.Investigators were unable to duplicate the original complaint.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
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7447629
• Report Number: 2531779-2018-07778
• Device Sequence Number: 1963782
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 04/14/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR