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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas and alleged that the patient experienced an elevated blood glucose above 500 mg/dl with no reported additional symptoms associated with the pump having an alleged no power issue.Reportedly, the patient continued pump therapy and did not receive any treatment above and beyond the usual routine of diabetes care and management.Troubleshooting with customer technical support (cts) could not be completed because the patient declined.This complaint is being reported based on the allegation that the patient experienced hyperglycemia and the pump could not be ruled out as a contributing factor.
Additional Manufacturer Narrative
Follow-up #1: date of submission (b)(4) 2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2018 with the following findings: a review of the black box showed the pump was running on the default year of 2007.An unexplained power on reset was recorded and deliveries were resumed.An unexplained power on reset occurred and deliveries were resumed.A replace cartridge alarm was recorded followed by a power on reset.No moisture/corrosion or damage was found in the battery compartment.The returned battery cap fully attached to the pump.The pump powered up with auditory and vibratory features.The pump was run for 24 hours with no power on resets.The returned battery cap measurements were within specifications.The total daily doses added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing and no delivery defects were found.The pump was delivering accurately within the required range.The pump cover was removed to find no evidence of internal moisture or damage to the power circuit.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: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7426838
• Report Number: 2531779-2018-07349
• Device Sequence Number: 11071079
• Product Code: LZG
• UDI-Device Identifier: 10840406101010
• UDI-Public: 10840406101010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 04/03/2018

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
• 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: 04/16/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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: Life Threatening
• Patient Age: 21 YR