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

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump 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 between 400-500 mg/dl during the night with high urinary ketones.The reporter also stated that the patient¿s blood glucose measurement on the meter has measured as ¿high¿ on the display indicating blood glucose level =600 mg/dl.The reporter did not provide any information regarding treatment the patient may have received associated with the reported hyperglycemic event(s).The reporter alleged the pump was experiencing an issue with losing prime beginning (b)(6) 2018 ¿causing the patient¿s blood glucose to go super high¿.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with a loss of prime issue.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8141302
• Report Number: 2531779-2018-20398
• Device Sequence Number: 1621498
• Product Code: LZG
• UDI-Device Identifier: 10840406101058
• UDI-Public: 10840406101058
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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): 11/20/2018

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/07/2018
• 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: 8 YR