MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. EASY TOUCH; LANCING DEVICE

Catalog Number 70473-03

Device Problem Defective Component (2292)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Depression (2361)

Event Date 06/20/2015

Event Type  Injury  

Event Description

Caller (customer's grandson/caregiver) reported the firing mechanism on the adc lancing device was defective and he was therefore unable to check the customer's blood glucose.Caller further reported that around (b)(6) 2015 or (b)(6) 2015, the customer experienced symptoms described as "not very active, depressed, tired".Customer was transported to a local hospital where she was diagnosed with hyperglycemia and treated with an insulin injection.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.Note: age entered is an approximation based on the birth year provided by the caller.Additionally, the device manufacturer date for the reported lancing device 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.

Manufacturer Narrative

This serves as a correction report.On the 30-day initial report was incorrectly selected as 'product problem'.Correct selection is 'adverse event'.Adverse event has been updated to reflect that the customer 'required intervention to prevent permanent impairment/damage'.

• Brand Name: EASY TOUCH
• Type of Device: LANCING DEVICE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 700
• Manufacturer Contact: meg manager ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 4940333
• MDR Text Key: 6036629
• Report Number: 2954323-2015-00363
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 70473-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2015
• Initial Date FDA Received: 07/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 50