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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

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.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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging the basal history did not match the programmed basal rates.It was reported the patient's blood glucose ranged from below 70 mg/dl and above 40 mg/dl to above 250 mg/dl and below 500 mg/dl with no signs or symptoms of hypoglycemia and hyperglycemia.The reported health event does not qualify as a serious injury.This complaint is being reported because the reported issue was not resolved with troubleshooting.

Manufacturer Narrative

Product analysis: the device was returned and evaluated by product analysis on 05/17/2016 with the following findings: the complaint could not be duplicated or confirmed with investigation.Review of the pump¿s black box revealed: a loss of prime on (b)(6) 2016 at 12:38 associated with a cartridge change; deliveries resumed at 16:35; a loss of prime following a rewind step on (b)(6) 2016 at 21:55.The pump was manually suspended on the same date at 22:17 follow by a rebooting event at 22:47.The pump powered on (b)(6) 2016 at 06:22; deliveries did not resume.The total daily dose history was appropriate for the user programmed delivery settings.The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm.The pump¿s history properly recorded all deliveries performed during investigation.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• 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: 5595122
• MDR Text Key: 43870967
• Report Number: 2531779-2016-08260
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• 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: 05/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2016
• 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 Age: 13 YR