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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 Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Follow-up #1: date of submission 05/15/2015 device evaluation: the device has been returned and evaluated by product analysis on 05/04/2015 with the following findings: the pump was completely operable with no evidence of any issues.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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.
 
Event Description
On (b)(6) 2015, the reporter contacted animas and alleged that the pump was not working.There was no further information available and troubleshooting was unable to be completed at the time of the call.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the reported issue was not resolved.
 
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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
jon mulberg
965 chesterbrook blvd
wayne, PA 19087
MDR Report Key10523318
MDR Text Key209618806
Report Number2531779-2020-00240
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/04/2015
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
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2015
Was the Report Sent to FDA? Yes
Device Age13 MO
Initial Date Manufacturer Received 05/04/2015
Initial Date FDA Received09/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24 YR
Patient Weight138
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