MAUDE Adverse Event Report: ANIMAS LLC; INSULIN INFUSION PUMP

Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
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 hyperglycemia while on insulin pump therapy evidenced by blood glucose measuring 307 mg/dl with moderate ketones present.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The reporter alleged the patient had been placed on a replacement pump the prior evening.Troubleshooting completed by animas customer support discovered that the customer had not programmed the replacement pump with the proper basal rates and rate per hour settings.Animas customer support assisted the customer in programming the replacement pump with the proper settings from the previous pump¿s programming during troubleshooting.This complaint is being reported because the patient experienced serious injury associated with a training/misuse issue.No pump malfunction was discovered during troubleshooting.

• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7836588
• Report Number: 2531779-2018-15794
• Device Sequence Number: 16481636
• Product Code: OYC
• UDI-Device Identifier: 10840406100372
• UDI-Public: 10840406100372
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 29 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/31/2018
• 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: 13 YR
• Patient Weight: 58