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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V. T90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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UNOMEDICAL DEVICES S.A DE C.V. T90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 5200835
Device Problems Loss of Power (1475); Product Quality Problem (1506); Device-Device Incompatibility (2919); Operating System Becomes Nonfunctional (2996)
Patient Problem Hyperglycemia (1905)
Event Date 07/07/2019
Event Type  malfunction  
Event Description
Received a brand of infusion sets for my insulin pump from ccs medical which i had never received before. The product was of poor quality and my insulin pump (accu-chek sprint combo) shut down and then froze. I was finally able to get my pump to work but no matter how much insulin i pumped my blood sugar remained in the 200 to 400 range. I called ccs medical and they said it was the only option i had. I then called medtronic, the company that provides support for the accu-chek pump which is no longer manufactured. They said the infusion sets from ccs medical were not compatible with my pump. There is an infusion set compatible with my pump which is manufactured by medtronic but (b)(6) says i must purchase from ccs medical which requires ccs medical to purchase from medtronic. Ccs medical said they are no longer purchasing infusion sets from medtronic and will purchase from tandem which gets the infusion sets from unomedical. Ccs medical claims the infusion sets are not made in (b)(4) even though it is printed on the infusion set box: legal mfr unomedical, made in (b)(4). I need (b)(6) to pay for my infusion sets and they will only pay ccs medical. (b)(6) gave me four other companies to contact for infusion sets but none of them provides infusion sets. Ccs medical is purchasing inferior products and sending them out to an unsuspecting public and the end user is being hurt. Their only response to me was they would be sending me more shipments after july 29th, even though i told them they do not work as intended. Fda safety report id# (b)(4).
 
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Brand NameT90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
UNOMEDICAL DEVICES S.A DE C.V.
MDR Report Key8785043
MDR Text Key150999789
Report NumberMW5088035
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2020
Device Lot Number5200835
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1
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