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); Nausea (1970); Polydipsia (2604)
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.(b)(4).
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas and alleged on (b)(6) 2018 the patient experienced a blood glucose of 417mg/dl, with nausea, polydipsia, and polyuria, associated with an alleged power damage issue.Reportedly, the patient discontinued pump therapy and resumed after replacement.The patient was treated in the emergency room by their healthcare provider with insulin via injection.During troubleshooting with customer technical support, it was revealed the battery compartment was cracked, and there was no power to the pump.The patient allegedly used different batteries without success.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with a no power issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 28-aug-2018 with the following findings: during investigation, the black box shows a low battery alert and a pump reboot.The pump was powered back and a pump reboot occurred.The deliveries resumed.The last basal delivery was on 2018-08-01.Battery compartment is cracked on the side from threads to cover.No moisture/corrosion observed in the battery compartment.The returned battery cap has stripped threads & was unable to maintain electrical connection, reported ¿power¿ complaint was duplicated.A new test battery cap was able to fit to maintain electrical connection.Pump boots to verify screen with audible & vibratory features.Test battery cap was used to complete a duration test; no por¿s were duplicated during this time.The total daily dose added up correctly and reflected the users programmed basal rates.Pump passed delivery accuracy test and was found to be delivering accurately and within range.The pump cover was removed; no evidence of internal moisture or damage to the power circuit was found.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7780394
• Report Number: 2531779-2018-14769
• Device Sequence Number: 14037440
• Product Code: OYC
• UDI-Device Identifier: 10840406100235
• UDI-Public: 10840406100235
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• 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): 07/28/2018

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: 08/23/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Initial Date Received by Manufacturer: 07/28/2018
• Supplement Date Received by Manufacturer: 07/28/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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; Required Intervention
• Patient Age: 20 YR
• Patient Weight: 37