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

Device Problem Device Issue (2379)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Confusion/ Disorientation (2553)

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.(b)(4).

Event Description

The reporter contacted animas on (b)(6) 2018 alleging the patient experienced hypoglycemia while on insulin pump therapy with blood glucose measuring 40-60 mg/dl with confusion, difficulty speaking and severe dizziness.The patient reportedly did not receive any treatment above or beyond the usual routine of diabetes care and management.The patient reportedly drank several bottles of juice to elevate the blood glucose level.The reporter alleged a history/settings issue; the basal history does not match the active basal program by >5% difference.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with an alleged history/settings issue.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 07-jun-2018 with the following findings: a review of the basal history and total daily dose history for 2018-(b)(4) correctly matched the active basal program.The total daily doses added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.The pump was exercised for 24 hours with a 2.0 unit per hour basal rate.At the end of testing the basal history correctly showed 2.0 units and the total daily doses showed 48.0 units.No alarms or delivery interruptions occurred during the testing.The allegation of a total daily dose or basal history recording defect was unable to be duplicated during testing.Unrelated to the original complaint, the battery compartment was cracked above and below bumper pad.Additionally, the cartridge compartment was damaged at the threads.

• 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: 7517269
• MDR Text Key: 108349971
• Report Number: 2531779-2018-09078
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 05/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/05/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/05/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 28 YR
• Patient Weight: 170