MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE INSULINX; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 71143-70

Device Problem Crack (1135)

Patient Problems Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418); Sweating (2444)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported a broken screen of the freestyle insulin meter and she was unable to read her glucose results during test.On (b)(6) 2019, customer self-treated with insulin (type/dose unknown) and experienced symptoms of ¿extreme low, excessive sweating, vomiting and subsequently passed out.The customer was unable to self-treat and her roommate treated her with ¿juice¿ and then an ambulance was called.Upon their arrival, a reading of 1.8 mmol/l (32.4 mg/dl) was obtained on their meter and customer was diagnosed with hypoglycemia.The customer was treated with ¿juice¿ until her blood glucose level rise from 2.0 mmol/l ¿ 4.0 mmol/l.No further treatment was required.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specifications.The dhrs (device history review) for the freestyle insulinx meter was reviewed.The dhrs showed the freestyle insulinx meter passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.

Event Description

Customer reported a broken screen of the freestyle insulinx meter and she was unable to read her glucose results during test.On (b)(6) 2019, customer self-treated with insulin (type/dose unknown) and experienced symptoms of ¿extreme low, excessive sweating, vomiting and subsequently passed out.The customer was unable to self-treat and her roommate treated her with ¿juice¿ and then an ambulance was called.Upon their arrival, a reading of 1.8 mmol/l (32.4 mg/dl) was obtained on their meter and customer was diagnosed with hypoglycemia.The customer was treated with ¿juice¿ until her blood glucose level rise from 2.0 mmol/l ¿ 4.0 mmol/l.No further treatment was required.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE INSULINX
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8996825
• MDR Text Key: 157764519
• Report Number: 2954323-2019-07012
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K120568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71143-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 59