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

Model Number	11001-1
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's products have been requested for an investigation.A follow-up report will be filed once additional information is obtained.The manufacturing date is unknown.The date is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving erratic readings while using an omnipod device with adc freestyle test strips.Customer reported receiving readings of 39 mg/dl, 266 mg/dl and 200 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed in specification and passed.A tripped trend review was conducted for the reported complaint and fs freedom meter, 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.
Event or Problem Description
Customer reported receiving erratic readings while using an omnipod device with adc freestyle test strips.Customer reported receiving readings of 39 mg/dl, 266 mg/dl and 200 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE
• 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: 8940167
• Report Number: 2954323-2019-06644
• Device Sequence Number: 2609644
• Product Code: NBW
• UDI-Device Identifier: 00699073121011
• UDI-Public: 00699073121011
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K092638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 11001-1
• Device Catalogue Number: 12101
• Device Lot Number: 1070764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 27