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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS LLC ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP
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ANIMAS LLC ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP Back to Search Results
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to animas for evaluation.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, alleging a message that the bg was greater than 15 minutes old.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may lead to a delay in treatment.
 
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Brand Name
ONETOUCHPING GLUCOSEMGMTSYSTEM
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
MDR Report Key8146604
Report Number2531779-2018-20417
Device Sequence Number1487541
Product Code LZG
UDI-Device Identifier00353885010207
UDI-Public00353885010207
Combination Product (Y/N)Y
Initial Reporter StateNY
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/02/2018
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Device Age11 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/02/2018
Initial Report FDA Received Date12/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age11 YR
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