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

Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had experienced a hyperglycemic event while on the pump.The reporter stated that the patient had a blood glucose of 550 mg/dl with symptoms of excess urination and moderate ketones.The patient did not receive any treatment above and beyond the normal course of diabetes management.The reporter stated that the pump was not displaying the correct amount of insulin remaining.The reporter alleged that the pump displayed 55 units of insulin left when there was no insulin in the cartridge.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event and the pump did not appear to be reading the correct amount of insulin present.
Additional Manufacturer Narrative
Follow-up #1: device evaluation: the device has been returned and evaluated by product analysis on 01-may-2018 with the following findings: a review of the black box showed evidence of cartridges being loaded.The last bolus delivery was a 3.70 unit bolus.No debris was observed in the cartridge compartment.No alarms related to the complaint were observed in the black box or alarm history.The remaining insulin was calculated accurately during testing.The pump was primed until 10 units remained in the cartridge at which point a low cartridge warning was given.The cartridge was removed and 10 units were visually confirmed to be remaining.The total daily doses added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing with no delivery defects found.The pump wa found to be delivering within the required range and delivering accurately.No alarms or delivery interruptions occurred during the testing.The complaint was unable to 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: 7472016
• Report Number: 2531779-2018-08188
• Device Sequence Number: 19136584
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/09/2018

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
• 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: 04/13/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR