MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FS PREC-NO CODING; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71577-75
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been returned, and the investigation is currently in process.A supplemental report will be submitted once all investigation activities are complete.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Reader mcga217-j4248 has been returned and investigated with retained test strips.Visual inspection has been performed on the reader and no issues were observed.Control solution testing was performed and no issues were performed.All results were within range specification.No malfunction or product deficiency was identified.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhr for the libre reader indicated by the serial number provided by the customer.The dhr showed the libre reader passed all tests prior to release.Dhr for the precision strips indicated by the serial number provided by the customer.The dhr showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in specification and passed.If the partial product is returned, a physical investigation will be performed, and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FS PREC-NO CODING
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 11633809
• Report Number: 2954323-2021-65916
• Device Sequence Number: 14373556
• Product Code: QLG
• UDI-Device Identifier: 00093815715771
• UDI-Public: 00093815715771
• Combination Product (Y/N): N
• PMA/510(K) Number: K193371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 71577-75
• Device Catalogue Number: 71577
• Device Lot Number: 4500184017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 95