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

Device Problems Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump 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.No conclusions can be made at this time.(b)(6).Follow-up #1: device evaluation: the pump has been returned and evaluated by product analysis on (b)(6) 2015 with the following findings: a review of the pump¿s alarm history showed cs 064 call service alarms.During testing, the pump powered on with no alarms.The rewind, load cartridge, and prime sequence was performed successfully.The pump was exercised for 24 hours and no call service alarms were emitted.The complaint of the call service alarm issue was shown in the pump history but was not duplicated during investigation.Unrelated to the complaint, investigation revealed that the display was dim and discolored.The battery compartment was observed to be cracked in two places.The battery cap was found to be damaged with stripped threads.A test cap was able to tighten fully to the pump.The pump was opened and no evidence of the corrosion or damage on motor flex connector was found.The pump has not been returned to animas for evaluation.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.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)(6).This report takes the place of 2531779-2015-37923, initial 3500a, originally submitted on 10/20/2015; resubmitted per fda esg request on 12/10/2015.This is being not considered a late as the report was initially submitted to fda within 30 days of awareness and is being resubmitted related to technical issues.

Event Description

On (b)(6) 2015, the reporter contacted animas, alleging a call service alarm (cs 064) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: jon mulberg ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 10528087
• MDR Text Key: 206775138
• Report Number: 2531779-2020-00252
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Was the Report Sent to FDA?: Yes
• Device Age: 38 MO
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1