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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
Health Effect - Clinical Codes	Hyperglycemia (1905); Urinary Frequency / Polyuria (2275); Lethargy (2560)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had experienced a hyperglycemic event while on the pump.The reporter stated that the patient had a blood glucose of over 500 mg/dl with symptoms of drowsiness and excess urination.The patient did not receive any treatment above and beyond the normal course of diabetes management.The reporter stated that the patient experienced the blood glucose excursion after the pump stopped working.The reporter alleged that this was related to a power issue with the pump.The battery cap was found to be damaged.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event while on the pump due to a power issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 18-oct-2018 with the following findings: the battery compartment was found to be cracked.A test cap was unable to fully tighten to the pump, but was able to power it on.There was evidence of moisture corrosion visible in the battery compartment.The pump's current draws were within specifications.The pump passed a delivery accuracy test with no issues.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7850149
• Report Number: 2531779-2018-16120
• Device Sequence Number: 19148292
• Product Code: OYC
• UDI-Device Identifier: 10840406100198
• UDI-Public: 10840406100198
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/10/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/30/2018
• 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: 47 YR