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

Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Headache (1880); Hypoglycemia (1912); 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.(b)(4).
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas and alleged that the patient experienced low blood glucose (bg) of 44 mg/dl with a severe headache, a stomach ache, shakiness and unsteadiness when standing and walking associated with an alleged inaccurate delivery.Reportedly, the patient discontinued pump therapy and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support (cts), it was revealed that the basal delivery totals in the total daily dose matched as programmed and the basal history matched the active basal program settings.Troubleshooting indicated all bolus settings and histories were correct and the pump was calculating bolus dosages correctly.Troubleshooting also indicated the following diabetes management factors contributed to the alleged bg excursion: a recent severe hypoglycemia.The reported alleged that the pump¿s delivery of insulin was not accurate since around 40 units of insulin seemingly disappeared.There were no defects found with the pump but it is being replaced because of insistence from a healthcare provider who believes the pump is unsafe.This complaint is being reported based on the allegation that the patient experienced hypoglycemia because of an alleged inaccurate delivery issue.
Additional Manufacturer Narrative
Follow-up #1: date of submission: 30-mar-2018.Device evaluation: the device has been returned and evaluated by product analysis on 03/23/2018 with the following findings: on investigation, the pump powered on normally and was exercised for 24 hours without any errors, alarms or warnings.At the conclusion of the exercise all deliveries were recorded as accurate according to the programmed settings.Investigation did not duplicate the complaint and the pump was found to be operating as intended without malfunction.

• 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: 7339789
• Report Number: 2531779-2018-05341
• Device Sequence Number: 10793678
• Product Code: LZG
• UDI-Device Identifier: 10840406101010
• UDI-Public: 10840406101010
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/19/2018

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: 03/08/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 0 MO
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 03/30/2018
• 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
• Patient Age: 11 YR