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

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoglycemia (1912)
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) 2016, the reporter contacted animas and alleged that on (b)(6) 2016, the patient had a blood glucose lower than 20 mg/dl, with cognitive impairment.The patient was treated in the emergency room with iv glucose.During troubleshooting, customer support found that the time and date reset to default when the battery was removed from the pump for less than 24 hours.The time and date issue complaint is not being reported based on the following: the pump displays the verify screen after it is rebooted and the time and date must be set to confirm the verify screen.This complaint is being reported as cs attributed the hypoglycemia to use error.
Additional Manufacturer Narrative
The device has been returned and evaluated by product analysis on 02/15/2017 with the following findings:.Unable to verify the time/date reset to default setting in the black box.A manual date/time change was made from (b)(6) 2016 14:27 to (b)(6) 2016 14:29.The pump history shows the pump was running on default year from (b)(6) 2016 to (b)(6) 2016.Pump was exercised for 24hrs.After 24hrs the battery was removed for 6hrs.The bench testing confirmed when the battery was reinserted after 6hrs without power the time and date reset to default setting.The tdd¿s add up correctly and reflect the users programmed basal rates.Pump passed delivery accuracy test and was found to be delivering accurately and within range.Removed cover; a visible inspection confirmed the internal battery was leaking.Audio bolus button cover is torn; the button is still operable.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: 6016658
• Report Number: 2531779-2016-28097
• Device Sequence Number: 16163367
• Product Code: LZG
• UDI-Device Identifier: 10840406100822
• UDI-Public: 0110840406100822
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/07/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 03/06/2017
• 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
• Patient Age: 16 YR
• Patient Weight: 75