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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
Device Problem Pumping Problem (3016)
Patient Problems Hypoglycemia (1912); Dizziness (2194); Ambulation Difficulties (2544)
Event Type  Injury  
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 Description
On (b)(6) 2018, the reporter contacted animas and alleged the patient experienced a blood glucose of 63mg/dl, with unsteadiness when standing and walking, and severe dizziness, associated with an alleged inaccurate delivery issue.Reportedly, the patient remained on the pump, and self-treated with food and/or drink.During troubleshooting with customer technical support, it was revealed the basal delivery totals in total daily dose matched the active basal program total.The basal history matched the active basal program settings.The bolus totals did not match.This complaint is being reported based on the allegation that the patient experienced hypoglycemia associated with an inaccurate delivery issue.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 17-dec-2018 with the following findings: during investigation, the complaint regarding iob not calculating correctly was not duplicated.Investigation delivered two 10 unit boluses , iob totaled 20 units.The ez bg results calculated and iob of -20.4.The pump passed all required testing.Testing was unable to duplicate or verify complaints.The complaint regarding bolus deliveries are not adding up with tdd was not duplicated or verified.Bolus totals from (b)(6)/2018 to end of use were reviewed and added up accurately with total daily dose.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.
 
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Brand Name
ONETOUCHPING GLUCOSEMGMTSYSTEM
Type of Device
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer (Section G)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer Contact
kristen lopolito
965 chesterbrook blvd
wayne, PA 19087
MDR Report Key8057783
MDR Text Key126885906
Report Number2531779-2018-19452
Device Sequence Number1
Product Code LZG
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K080639
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/27/2018
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 10/27/2018
Initial Date FDA Received11/09/2018
Supplement Dates Manufacturer Received10/27/2018
Supplement Dates FDA Received12/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age63 YR
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