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

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Codes	Hyperglycemia (1905); No Code Available (3191)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 16-dec-2018 with the following findings: during investigation, the black box from the date of the complaint had been overwritten.The available black box showed a loss of prime related to the replace cartridge alarm, cartridge change and the pump not being primed after the rewind.There were no unexplained loss of prime events observed.The last basal delivery was on (b)(6) 2017.An ez prime and 24 hr duration test were successfully completed with no loss of prime warnings being duplicated.The force sensor measured within specification.The total daily dose added up correctly and reflected the users programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.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.(b)(4).
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas alleging that the patient experienced a blood glucose of 400 mg/dl with large ketones associated with an alleged loss of prime issue.Reportedly, the patient discontinued pump therapy and was treated at the hospital by their health care provider with intravenous fluids.During troubleshooting with customer technical support, it was noted that this occurred 2 or more times even after the patient used a cartridge from another box and occurred with at least 3 separate cartridges from 2 separate boxes.This complaint is being reported because the patient experienced hyperglycemia associated with an alleged loss of prime issue.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7201492
• Report Number: 2531779-2018-01142
• Device Sequence Number: 1277296
• Product Code: LZG
• UDI-Device Identifier: 10840406101010
• UDI-Public: 10840406101010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 12 YR