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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

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INSULET CORPORATION OMNIPOD 5; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Omnipod 5 on immediate backorder after launch.People that need this product left with no alternatives after singing up for their contract.Fda safety report id# (b)(4).
 
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Brand Name
OMNIPOD 5
Type of Device
INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key15249577
MDR Text Key298401903
Report NumberMW5111552
Device Sequence Number1
Product Code QJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/15/2022
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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