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

Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Vomiting (2144)
Type of Reportable Event	Death
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.(b)(4).
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 600 mg/dl with symptoms of nausea, vomiting, lethargy, chest pain, thirst, and sweating.The patient was being taken to the hospital for their blood glucose excursion.There was no information on treatment that the patient received.The reporter stated that the keypad buttons were unresponsive.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event while on the pump.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 19 -dec-2018 with the following findings: during investigation, the ,pump was placed into suspend on (b)(6) 2018 and deliveries were resumed on (b)(6) 2018 at 13:41.A battery compartment cracked from threads to case seal.2.Pump passed all required testing including delivery accuracy.All keys respond , no evidence of damaged or intermittent keypad was duplicated.Keypad and [pump cover was removed no evidence of moisture, contamination or pump keypad flex defects.According to the pump history, the pump was delivering the programmed basal rate on (b)(6) 2018 until the pump alarmed empty cartridge warning.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: 7788407
• Report Number: 2531779-2018-14992
• Device Sequence Number: 2446440
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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: 12/12/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 24 YR