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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905); Vomiting (2144)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging the patient¿s blood glucose (bg) on (b)(6) 2017 was 1300 mg/dl with large ketones, abdominal pain, nausea, and vomiting.The reporter noted the patient was hospitalized and treated with intravenous fluids and insulin drip, they remained on pump therapy with replacement, and the pump¿s delivery settings were not recently changed by a healthcare provider.During troubleshooting, it was reported that the pump was programmed with only one basal program.It was reported that the pumps basal history and total daily dose basal history were appropriate for the programed basal rates; the bolus history matched the total daily dose bolus history; the bolus history recorded was accurate as programed; the pump was calculating recommended bolus totals correctly.There was no indication of a device malfunction.This complaint is being reported because the reported health event 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: 6796993
• Report Number: 2531779-2017-18372
• Device Sequence Number: 16460668
• Product Code: LZG
• UDI-Device Identifier: 10840406100822
• UDI-Public: 0110840406100822
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/17/2017

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
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/16/2017
• 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: Hospitalization; Life Threatening
• Patient Age: 31 YR