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

Model Number	71411-70
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation.A follow- up report will be submitted once additional information is obtained.Note: the meter is designed to report readings of 20 mg/dl to 500 mg/dl.It should be noted that this meter does not give numeric value for readings less than 20 mg/dl.A "lo" display message indicates a reading less than 20 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported that a patient received a lower than expected reading on a hospital adc blood glucose meter.A health care professional reported receiving a reading of less than 20 mg/dl("lo" display message indicates a reading less than 20 mg/dl), which was lower than lab reading of 135 mg/dl.The results fell into the "c" zone showing the difference in values to be clinically significant.There was no death, serious injury or mistreatment associated with this event.
Additional Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A dhr (device history review) for the precision xceed pro meter has been reviewed and the dhr showed the precision xceed pro meter passed all tests prior to release.Dhrs for the precision strips has been reviewed and the dhrs showed the precision strips passed all tests prior to release.Strip lot 4c4e5h was past its expiry date of may 31, 2018 therefore, retain testing was not performed for this lot.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
A health care professional reported that a patient received a lower than expected reading on a hospital adc blood glucose meter.A health care professional reported receiving a reading of less than 20 mg/dl("lo" display message indicates a reading less than 20 mg/dl), which was lower than lab reading of 135 mg/dl.The results fell into the "c" zone showing the difference in values to be clinically significant.There was no death, serious injury or mistreatment associated with this event.

• Brand Name: PRECISION FREESTYLE PRO
• 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: 7305060
• Report Number: 2954323-2018-01740
• Device Sequence Number: 1211960
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: (01)00093815709329(17)20180531(10)4C4E5H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: Health Professional
• Device Model Number: 71411-70
• Device Catalogue Number: 70932
• Device Lot Number: 4C4E5H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1