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

Model Number	71181-70
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A caller from a hemodialysis clinic reported their clinic adc meter did not work when they attempted to perform a customer's a blood glucose check by inserting the test strip into the meter.On (b)(6) 2019, the customer exhibited unspecified symptoms of hypoglycemia and was treated by an hcp with "sugar gel" and rushed to the hospital.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Meter (b)(4) has been returned and investigated using retain test strips.Visual inspection has been performed and no issues were observed.Meter powered on with button depression and with insertion of cal bar and strips.No observed port issue on meter.Meter was able to advance to control testing solution assays, and menu set-up.No malfunction or product deficiency identified.
Event or Problem Description
A caller from a hemodialysis clinic reported their clinic adc meter did not work when they attempted to perform a customer's a blood glucose check by inserting the test strip into the meter.On (b)(6) 2019, the customer exhibited unspecified symptoms of hypoglycemia and was treated by an hcp with "sugar gel" and rushed to the hospital.There was no report of death or permanent injury associated with this event.
Event or Problem Description
A caller from a hemodialysis clinic reported their clinic adc meter did not work when they attempted to perform a customer's a blood glucose check by inserting the test strip into the meter.On (b)(6) 2019, the customer exhibited unspecified symptoms of hypoglycemia and was treated by an hcp with "sugar gel" and rushed to the hospital.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported strips were not returned.An extended investigation was performed on 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 precision strips were reviewed and the dhr showed the strips passed all tests prior to release.Retain testing was performed and all units performed within specification.If the reported strips are returned, the case will be re-opened, and a physical investigation will be performed.This also serves as a correction report.Emdr-64092 was incorrectly filed as an initial mdr 30 day report.Emdr-64092 should have been documented as follow up #1.Emdr-64875 should have been documented as follow up #2 and emdr-82583 is follow up #3.

• Brand Name: FREESTYLE PRECISION H
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8634096
• Report Number: 2954323-2019-04115
• Device Sequence Number: 19286646
• Product Code: NBW
• UDI-Device Identifier: 00093815711810
• UDI-Public: 00093815711810
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K070984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 71181-70
• Device Catalogue Number: 71181
• Device Lot Number: 4500181259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 02/05/2020
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/26/2019; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention