MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144)
Date of Event	12/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to animas.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
On (b)(6) 2018, the reporter contacted animas alleging that on (b)(6) 2017, the patient initiated a 911/emergency protocol and was hospitalized for an elevated blood glucose (bg) of 502 mg/dl with vomiting associated with an alleged prime issue.Reportedly, the patient remained hospitalized and was treated by a healthcare provider and received intravenous (iv) fluids as treatment.It could not be determined whether or not the patient continued pump therapy.During troubleshooting with customer technical support (cts), it was revealed that the patient was not priming the pump per instructions for use (ifu) which likely led to the perceived prime issue.The reporter did not know the type of infusion set that was being used with the pump.The reporter was advised if they were using an animas product they were not using those infusion set per ifu and advised to them to prime the tubing until they see 4 to 5 drops come out of the end of the tubing.It was also reported that the patient was under a lot of family stress as well.It was determined that the pump was working properly.This complaint is being reported because there was a bg excursion requiring medical intervention associated with training/misuse of the pump.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7222996
• Report Number: 2531779-2018-01985
• Device Sequence Number: 19408281
• Product Code: OYC
• UDI-Device Identifier: 10840406100372
• UDI-Public: 10840406100372
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 01/02/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/26/2018
• 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: 16 YR
• Patient Weight: 85