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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 Appropriate Device Problem Term/Code Not Available (3191)
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 the patient¿s blood glucose was over 600 mg/dl, associated with an alleged inaccurate delivery issue.The reporter was not able to provide further information during the initial complaint.Customer technical support made attempts to contact the reporter for additional information and troubleshooting, without success.This complaint is being reported because the patient allegedly experienced hyperglycemia while on the insulin pump, and the pump could not be ruled out as a contributing factor.
 
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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 Key7211789
Report Number2531779-2018-01560
Device Sequence Number764007
Product Code LZG
UDI-Device Identifier10840406101010
UDI-Public10840406101010
Combination Product (Y/N)N
Initial Reporter StateOH
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 Other Caregivers
Type of Report Initial
Report Date (Section B) 01/19/2018
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? No
Operator of Device Lay User/Patient
Other Device ID Number1-MCBC-64
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Device Age15 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2018
Initial Report FDA Received Date01/23/2018
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 Age14 YR
Patient Weight34
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