MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. PRECISION XCEED 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	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
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 or lower than 20 mg/dl.A "hi" display message indicates a reading higher than 500 mg/dl and a "lo" display message indicates a reading lower than 20 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter within 10 minutes.Results of "hi" ( >500 mg/dl) and "lo" ( <20 mg/dl) were plotted on the parkes error grid.The results fell into the "d" 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.In addition, retained test strip samples from the same lot reported by the customer (4c785h) were tested with control solution.All results were within the range specification and no errors were observed.Product was performing within specification.(meter serial number) was incorrectly documented in the initial mdr 30 day report.Meter serial number has been updated.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter within 10 minutes.Results of "hi" ( >500 mg/dl) and "lo" ( <20 mg/dl) were plotted on the parkes error grid.The results fell into the "d" 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 test strips were not 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.The reported meter was previously returned and investigated.Therefore, no further investigation activities will be performed for the xceed pro meter.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
Customer reported receiving erratic readings on their adc blood glucose meter within 10 minutes.Results of "hi" ( >500 mg/dl) and "lo" ( <20 mg/dl) were plotted on the parkes error grid.The results fell into the "d" 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
See section h11 (corrected data).All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section g-7 (follow up #) was incorrectly documented as follow up #3 in the previous mfr 2954323-2017-07873.G-6 has been correctly updated to follow up #2.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter within 10 minutes.Results of "hi" ( >500 mg/dl) and "lo" ( <20 mg/dl) were plotted on the parkes error grid.The results fell into the "d" 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: PRECISION XCEED PRO
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• Manufacturer (Section G): ABBOTT DIABETES CARE INC.; abbott diabetes care inc.; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 7031977
• Report Number: 2954323-2017-07873
• Device Sequence Number: 117825
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: (01)00093815709329(17)20180831(10)4C785H
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K080960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2018

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: 08/31/2018
• Device Model Number: 70900-01
• Device Catalogue Number: 70932
• Device Lot Number: 4C785H
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 12/21/2017; 11/20/2018; Not provided
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/27/2017; 09/11/2023; 12/14/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown