MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LANCING DEVICE II

Model Number 71582-01

Device Problem Material Separation (1562)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and lancing device, no trends were identified that would indicate any product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The customer reported that her adc lancing device separated on (b)(6) 2020.The customer attempted to continue to use the device, but reported the device would keep separating.The customer had no symptoms prior to losing consciousness while sleeping, and was taken to a hospital on (b)(6) 2020.The customer was diagnosed with hypoglycemia, and treated with glucose via injection.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section d4 - serial number was updated based on returned product.The reported device was returned and visually assessed.As part of the line assembly of these devices, 100% inspection is carried out.The damage associated by ¿cracking¿ the body along the seam line and dislodging the central connection is not consistent with any om process or typical ifu (instruction for use).However, the probable cause is likely attributed to the user attempting to ¿snap¿ open the device at the joint line, instead of the cap, causing the reported failure mode.This issue therefore is not confirmed to user handling issues.

Event Description

The customer reported that her adc lancing device separated on (b)(6) 2020.The customer attempted to continue to use the device, but reported the device would keep separating.The customer had no symptoms prior to losing consciousness while sleeping, and was taken to a hospital on (b)(6) 2020.The customer was diagnosed with hypoglycemia, and treated with glucose via injection.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LANCING DEVICE II
• Type of Device: LANCING DEVICE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 9714424
• MDR Text Key: 180102794
• Report Number: 2954323-2020-01293
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71582-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR