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

Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Headache (1880); Hypoglycemia (1912); Ambulation or Postural Difficulties (2544)
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.No conclusions can be made at this time.
Event or Problem Description
The reporter contacted animas on (b)(6) 2018 alleging the patient experienced hypoglycemia while on insulin pump therapy evidenced by blood glucose measuring 40 mg/dl accompanied by unsteadiness when standing and walking and severe headache.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The reporter did not provide any information regarding treatment of the hypoglycemia.The reporter alleged the pump was delivering more insulin that it was programmed to deliver to the patient.The reporter did not complete troubleshooting of the pump with animas customer support.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with an alleged inaccurate insulin delivery issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 28 -jan-2019 with the following findings:.During investigation, the black box and alarm history showed no evidence of insulin remaining issues.The pump total daily dose (tdd) history confirmed the pump was delivering the programmed basal rate.The pump passed all required testing for delivery accuracy and insulin remaining.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8037607
• Report Number: 2531779-2018-19110
• Device Sequence Number: 1463762
• Product Code: LZG
• UDI-Device Identifier: 10840406101010
• UDI-Public: 10840406101010
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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
• Patient Age: 12 YR