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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 Device Issue (2379)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been returned to animas.If the device is returned, an evaluation will be completed.No conclusions can be made at this time.
 
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas and alleged that the patient had initiated their emergency protocol and was hospitalized, unwilling to provide additional information.This complaint is being reported as the pump could not be excluded as a cause/contributor to the emergency hospitalization.
 
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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 Key6456484
Report Number2531779-2017-06953
Device Sequence Number562982
Product Code LZG
UDI-Device Identifier10840406101126
UDI-Public0110840406101126
Combination Product (Y/N)N
Initial Reporter StateFL
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) 03/09/2017
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
Other Device ID Number1-MCBC-64
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Device Age12 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/09/2017
Initial Report FDA Received Date04/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age65 YR
Patient Weight175
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