MAUDE Adverse Event Report: ANIMAS LLC ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Device Problem Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Sweating (2444); Shaking/Tremors (2515)

Event Type  Injury  

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.No conclusions can be made at this time.

Event Description

The reporter contacted animas on 19-jul-2018 alleging that on (b)(6) 2018 the patient experienced hypoglycemia while on insulin pump therapy evidenced by blood glucose measuring 38 mg/dl with diaphoresis, nervousness and shakiness.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The reporter alleged the pump was delivering 100 units of insulin through the night with the pump set to deliver 1 unit.The reporter stated that the patient¿s health care provider adjusted the basal rate in the pump settings.The reporter declined to complete troubleshooting of the device with animas customer support and remained on pump therapy.This complaint is not being reported because the issue was determined to involve diabetes management as the patient¿s health care provider had made adjustments to the basal settings in the pump; however, device malfunction could not be ruled out because troubleshooting of the device was refused by the reporter.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7756683
• MDR Text Key: 116229510
• Report Number: 2531779-2018-14303
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 32 MO
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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): Life Threatening
• Patient Age: 69 YR
• Patient Weight: 205