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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dysphasia (2195); Confusion/ Disorientation (2553)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas alleging the patient's blood glucose on an unknown date was 40 mg/dl with difficulty speaking, unsteadiness when standing and walking, severe dizziness, blurred vision, confusion, severe headache.The reporter noted the patient did not receive any treatment above and beyond the usual routine of diabetes care and management, they remained on pump therapy, and the pump¿s delivery settings were not recently changed by a healthcare provider.During troubleshooting, it was reported that the patient incorrectly set the pump's time.There was no indication or allegation of a device malfunction.This complaint is being reported because the reported health event is was attributed to a device use-error.

• 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: 7036146
• Report Number: 2531779-2017-26650
• Device Sequence Number: 11048948
• Product Code: LZG
• UDI-Device Identifier: 10840406101126
• UDI-Public: 0110840406101126
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 10/28/2017

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2017
• Initial Report FDA Received Date: 11/15/2017
• 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: 54 YR
• Patient Weight: 164