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

Medical Device Problem Codes	Use of Device Problem (1670); Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
Health Effect - Clinical Codes	Hyperglycemia (1905); Lethargy (2560)
Type of Reportable Event	Serious Injury
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 (bg) measuring 547mg/dl with drowsiness.The patient alleged that elevation occurred from receiving call service alarm (064) due to blockage in tubing.The patient reports being out of cartridges and was re-using them.Customer technical support (cts) was unable to complete troubleshooting of the call service alarm at the time of the initial call.A follow up call by cts to complete troubleshooting was done.At that time the reporter alleged patient was hospitalized for the high bg issue.The reporter was unable to provide any details of the hospitalization.No further troubleshooting of the pump was able to be completed.An additional attempt was made to complete troubleshooting but was unsuccessful.This complaint is being reported for alleged hyperglycemia associated with pump use for which it was determined that diabetes management related to the lack of proper supplies as well as training misuse associated with the re-use of single-use supplies which may have been associated with the occlusion during the prime step as indicated by the call service 064 alarm were contributing factors.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8004275
• Report Number: 2531779-2018-18778
• Device Sequence Number: 16250305
• Product Code: LZG
• UDI-Device Identifier: 10840406100990
• UDI-Public: 10840406100990
• 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): 10/08/2018

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: 17 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/25/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 156