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

Model Number	70900-01
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported receiving a high adc reading of 87 mg/dl as compared to a laboratory reference reading of 20 mg/dl obtained 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
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.
Event or Problem Description
A health care professional reported receiving a high adc reading of 87 mg/dl as compared to a laboratory reference reading of 20 mg/dl obtained 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
Given no test strips were returned for investigation, retained test strip samples from the same lot reported by the customer (4c055h) were tested with control solution.All results were within the range specification and no errors were observed.The complaint is not confirmed.
Event or Problem Description
A health care professional reported receiving a high adc reading of 87 mg/dl as compared to a laboratory reference reading of 20 mg/dl obtained 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
This serves as a correction report.(describe event or problem) was incorrectly documented in the initial mdr 30 day report, mdr follow up #1 and #2.The corrected plotted readings of 87 mg/dl and 21 mg/dl have been updated.
Event or Problem Description
A health care professional reported receiving a high adc reading of 87 mg/dl as compared to a laboratory reference reading of 21 mg/dl obtained 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: 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
• MDR Report Key: 6549806
• Report Number: 2954323-2017-03517
• Device Sequence Number: 19149175
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: (01)00093815709329(17)20180131(10)4C055H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2017

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: 01/31/2018
• Device Model Number: 70900-01
• Device Catalogue Number: 70932
• Device Lot Number: 4C055H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; 07/13/2017; 11/27/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/26/2017; 07/19/2017; 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR