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

Model Number	70900-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/06/2017
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 higher than 500 mg/dl.A "hi" display message indicates a reading higher than 500 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported that receiving a high reading on a hospital adc blood glucose meter.A health care professional reported a reading of greater than 500 mg/dl when compared to a laboratory reading of 133 mg/dl.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
The reported meter was returned and investigated with retained test strips.The complaint was not confirmed and no new issues were observed.All results were within range specification and no errors were observed during control solution testing.Product was found to be functioning within specification.
Event or Problem Description
A health care professional reported that receiving a high reading on a hospital adc blood glucose meter.A health care professional reported a reading of greater than 500 mg/dl when compared to a laboratory reading of 133 mg/dl.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
Test strips have not 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.As the meter associated with this case was returned and no issues with the meter were observed, only activities related to the precision strips were performed.A dhr (device history review) for the precision strips was reviewed and the dhr showed the precision strips passed all tests prior to release.Retain testing was performed for the precision strips and all units performed within specification and passed.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 receiving a high reading on a hospital adc blood glucose meter.A health care professional reported a reading of greater than 500 mg/dl when compared to a laboratory reading of 133 mg/dl.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 PRECISION 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: 7123791
• Report Number: 2954323-2017-08856
• Device Sequence Number: 1288182
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: (01)00093815712848(17)20190131(10)8707PC
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2018

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 Expiration Date: 01/31/2019
• Device Model Number: 70900-01
• Device Catalogue Number: 71284
• Device Lot Number: 8707PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 09/25/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/18/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1