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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP
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ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP Back to Search Results
Medical Device Problem Code Date/Time-Related Software Problem (2582)
Health Effect - Clinical Codes Hyperglycemia (1905); Urinary Frequency / Polyuria (2275)
Date of Event 10/05/2017
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) 2017, the reporter contacted animas alleging the patient's blood glucose that day was 597 mg/dl with excess urination.It was reported the patient discontinued pump therapy and the delivery settings were not changed recently.Reportedly the patient received phone advice to self-treat with insulin via injection.It was reported that the pump's time setting reset to default when the battery was removed for less than 24 hours.This complaint is being reported because the reported adverse event was attributed to a device malfunction.
 
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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 Key6970821
Report Number2531779-2017-24554
Device Sequence Number16254567
Product Code LZG
UDI-Device Identifier10840406100822
UDI-Public0110840406100822
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K080639
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 10/05/2017
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
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 10/05/2017
Initial Report FDA Received Date10/23/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Patient Age9 YR
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