MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FS LIBRE SENSOR KIT; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Model Number 9027

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 08/17/2022

Event Type  Injury  

Event Description

This is to inform you that on date: (b)(6) 2022 we bought a fs libre sensor kit for sugar testing for my father as prescribed by doctor (b)(6) ((b)(6) hospital) from (b)(6).This machine was installed by the seller himself stating that in any kind of fault this machine will be replaced indefinitely.Within 2 days this machine stopped working and this caught a real hassle as my father is suffering from serious acute diabetes which has to be kept under a watch "24x7".However, when asked for help the seller blatantly refused and asked us to wait for 7 - 8 days.When reported of this matter to the local police station, i received a threatening call from the owner of this place stating that now that you have made a complaint he would take his own sweet time which can be more than a month which will be a punishment for us as we acted upon this harassment done by the owner of harkishan medicals.We request you to take acute and stern action against a person who is in such a responsible medical profession and has himself seen how much my father is suffering and is forcing us to go through this mental and emotional torture every day just because he wasn't able to do his work right the first time and wants my father to face the consequences of his wrong deeds.Please help us and bring this corruption to justice.Fda safety report id# (b)(4).

• Brand Name: FS LIBRE SENSOR KIT
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15282818
• MDR Text Key: 298595053
• Report Number: MW5111673
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2023
• Device Model Number: 9027
• Device Lot Number: 220429P
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ULTRAHUMAN APP
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: Asian