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); Lethargy (2560)
Type of Reportable Event	Malfunction
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 and alleged that the patient experienced an elevated blood glucose over 600 mg/dl with extreme drowsiness associated with an alleged time/date issue.Reportedly, the patient continued pump therapy and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support (cts), it was revealed that the pump¿s time was wrong because the patient was incorrectly setting the time.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an alleged time/date issue, with use error as a contributing factor.

• 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: 6886117
• Report Number: 2531779-2017-21969
• Device Sequence Number: 125046
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 0110840406100020
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 08/27/2017

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: 21 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2017
• Initial Report FDA Received Date: 09/22/2017
• 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: 72 YR