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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Death (1802); Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	01/21/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The pump 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) 2019, the reporter stated that the patient had a blood glucose (bg) of 44 mg/dl with confusion and cognitive impairment associated with an alleged inaccurate delivery.Reportedly, the patient was found unconscious with a blood glucose of 44 mg/dl.The patient discontinued pump therapy and was treated with intravenous glucose and other treatment.The patient was taken to the hospital via emergency medical services but was pronounced dead at the time of arrival.During troubleshooting with customer technical support, it was also reported that on the day of the patient¿s death, the patient was taking oxycodone for pain.The patient gave themselves a bolus of 7.7 units and the patient thought the pump said 0.0 units of the 7.7 units were delivered.It was found that 6.7 of the 7.7 units were delivered.The patient then changed the ifs and the cartridge and another bolus of 7.7 units was given.It was also reported that there was a change in physical activity level without adjustment to insulin regimen, change in medication, change in stress level, change in pain level, a recent severe hypoglycemia, and overriding dosage recommended by bolus calculator feature.This complaint is being reported because of user error that contributed to the patient¿s death.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8437249
• Report Number: 2531779-2019-02030
• Device Sequence Number: 2170690
• Product Code: LZG
• UDI-Device Identifier: 10840406101058
• UDI-Public: 10840406101058
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 21 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 03/20/2019
• 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: Death; Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 196