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

Medical Device Problem Code	Pumping Problem (3016)
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 hypoglycemic event while on the pump.The reporter stated that the patient had a blood glucose of 33 mg/dl with no associated symptoms of hypoglycemia.The reporter stated that the patient received orange juice as treatment to bring their blood glucose level up.The reporter was unable to complete troubleshooting at the time of the call.This complaint is being reported based on the allegation that the patient experienced a hypoglycemic event while on the pump.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07-mar-2019 with the following findings: a review of the black box and pump history showed no evidence of a delivery malfunction.The prime history indicated 9 prime events with an unknown cause.A zero basal record was recorded due to user intervention of cartridge and battery changes.The pump passed all required delivery accuracy testing.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 LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7569009
• Report Number: 2531779-2018-10230
• Device Sequence Number: 144148
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 05/24/2018

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: 02/14/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 03/11/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 10 YR