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

Device Problem Failure to Prime (1492)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

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 Description

On (b)(6) 2016, the reporter contacted animas and alleged that on (b)(6) 2016, the patient noticed a load step malfunction: the pump going to the load step but only loading for about 2 seconds even when minimal insulin is in cartridge, ex: 30u.Patient then checks the insulin remaining and it does not correlate with the amount left in the cartridge.The pump shows almost a full amount remaining even when only 30u in cartridge.Patient developed a blood glucose of 400 mg/dl with extreme drowsiness.Patient received unspecified treatment from the endocrinologist.This complaint is being reported as the issue may result in inaccurate delivery and the patient developed hyperglycemia.

Manufacturer Narrative

Follow-up #1: date of submission 12/14/2016 device evaluation: the device has been returned and evaluated by product analysis on 11/19/2016 with the following findings: no defect was found.No evidence of a load step malfunction observed in the black box.The black box shows an unexplained por (power on reset on (b)(6) 2016 20:17.Pump was powered back on (b)(6) 2016 06:56 but not primed & no deliveries were made.Pump was powered off at 07:10.Deliveries resumed on (b)(6) 2016 11:10.An unexplained por was observed on (b)(6) 2016 06:40; deliveries never resumed.No debris observed in cartridge compartment.Rewind, load & prime steps completed with no issues.A cartridge with approximately 190 u was inserted and recognized correctly by the piston rod.A 24 hr duration test was successfully completed.The pump is detecting the correct force.The tdd¿s add up correctly and reflect the users programmed basal rates.Pump passed delivery accuracy test and was found to be delivering accurately and within range.Removed pump cover; force sensor pins seated and solder connections intact.No evidence of contamination or cracked force sensor traces.No evidence of internal moisture was found.Unable to duplicate the reported complaint.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 6033129
• MDR Text Key: 57606368
• Report Number: 2531779-2016-28722
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100259
• UDI-Public: 0110840406100259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 183