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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905); Nausea (1970)
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) 2017, the reporter contacted animas alleging that the patient experienced an elevated blood glucose of 575 mg/dl with nausea, symptoms of dehydration (dizzy, lightheaded) and an unspecified level of ketones associated with an alleged suspend issue with the pump.Reportedly, the patient resumed with the same pump and self-treated with insulin via injection to lower their bg level.During troubleshooting with customer technical support (cts), it was revealed that the patient did not completely understand the pump¿s suspend feature and how to resume it correctly.It was also discovered that the patient had previously suspended the pump by accident.The patient was educated on the feature.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with training/misuse; no pump malfunction was indicated.

• 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: 7151217
• Report Number: 2531779-2017-29371
• Device Sequence Number: 840739
• Product Code: OYC
• UDI-Device Identifier: 10840406100266
• UDI-Public: 10840406100266
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 12/03/2017

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: 8 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2017
• Initial Report FDA Received Date: 12/28/2017
• 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: 80 YR