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

Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2017, the reporter contacted animas and alleged that the patient experienced an unspecified blood glucose (bg) level, initiated a 911/emergency protocol and was treated in the emergency room (er) by a healthcare provider on the same date with no reported additional symptoms associated with an alleged inaccurate delivery.The patient reported that they were seen in the er due to the pump allegedly not working.Information about the type of treatment received could not be obtained.It could not be determined whether or not the patient continued pump therapy.Troubleshooting with customer technical support (cts) could not be completed therefore the unspecified pump issue could not be confirmed.Follow-up calls from cts s were made to attempt to contact the patient but contact was unsuccessful and no additional information was obtained.If additional information is obtained, a follow-up report will be sent.This complaint is being reported based on the allegation that the patient experienced an adverse event requiring an initiation of a medical intervention and the pump could not be ruled out as a contributing factor.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 08-may-2018 with the following findings: the total daily doses of insulin appeared to be inaccurate due to the date being incorrectly set on the pump.The recorded total daily doses added up to the user's programmed basal rates.The pump passed a delivery accuracy test.The alleged issue could not be duplicated.

• 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: 7156298
• Report Number: 2531779-2017-29504
• Device Sequence Number: 63563
• Product Code: LZG
• UDI-Device Identifier: 10840406101010
• UDI-Public: 10840406101010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/06/2017

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
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/30/2017
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 20 YR