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

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).

• Brand Name: T90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A DE C.V.
• MDR Report Key: 8785043
• MDR Text Key: 150999789
• Report Number: MW5088035
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2020
• Device Lot Number: 5200835
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 68