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

Device Problem Device Issue (2379)

Patient Problems Headache (1880); Dysphasia (2195); Dysphasia (2195); Ambulation Difficulties (2544); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Confusion/ Disorientation (2553)

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.(b)(4).

Event Description

On (b)(6) 2017, the reporter contacted animas and alleged that on (b)(6) 2017 the patient was treated for a low blood glucose (bg) below 3 mmol/l with difficulty speaking, unsteadiness when standing and walking, confusion, and a severe headache associated with an alleged history/settings issue.The patient reportedly noticed that high and low alerts in the pump were not alarming (no vibration, no audible sound).The low and high alerts were enabled and set to the following: low alert 3.9 mmol/l and high alert 22.2 mmol/l.The patient noticed this for about 3 weeks now.Reportedly, the patient remained on the pump, received non-healthcare provider treatment and received food and/or drink as treatment.During troubleshooting with customer technical support (cts), it was revealed that the patient experienced a high and low bg on (b)(6) 2017 but in the pump history the high alert can be found but the low alert was missing.This complaint is being reported based on the allegation that the patient experienced hypoglycemia because of an alleged history/settings issue.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 11/08/2017 with the following findings: during testing, the pump powered on to the verify screen with audible and vibratory features.The pump successfully completed a rewind, load, and prime sequence.The pump¿s black box showed that the last basal delivery was on (b)(6) 2017.A test transmitter was correctly paired with the pump for testing purposes.The pump was returned with the sound features for the glucose user hi/lo limit alert, the transmitter out of range alert and the other cgm alert set to high; the glucose rise/fall rate alert was set to low.There were no high or low alerts observed in the cgm warning history on (b)(6) 2017.The cgm warning history did show evidence of high and low alerts indicating that the pump is capable of giving these alerts.A high and low alert were reproduced for the investigation; the pump gave the appropriate sound and displayed the correct message on the screen and both were accurately recorded in pump history.There were no errors, alarms or warnings which occurred during the investigation.The total daily doses (tdd¿s) added up correctly and reflected the user¿s programmed basal rates.The pump passed a delivery accuracy test and was found to be operating within required specification and delivery accurately.The initial complaint issue was not duplicated during investigation.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
• 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: 6814715
• MDR Text Key: 92212319
• Report Number: 2531779-2017-19003
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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: 09/26/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 0
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 39 YR