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 Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
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.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 high reading on a hospital adc blood glucose meter.A health care professional reported a reading of 404 mg/dl which was lower than lab reading of 9 mg/dl.The results fell into the "e" 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
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 that a patient received a high reading on a hospital adc blood glucose meter.A health care professional reported a reading of 404 mg/dl which was lower than lab reading of 9 mg/dl.The results fell into the "e" 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
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, 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.As the strip lot associated with this case was past its expiry date of march 31, 2018 at the time of investigation, retain testing was not performed.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 high reading on a hospital adc blood glucose meter.A health care professional reported a reading of 404 mg/dl which was lower than lab reading of 9 mg/dl.The results fell into the "e" 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 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: 7030012
• Report Number: 2954323-2017-07865
• Device Sequence Number: 155772
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: (01)00093815709329(17)20180331(10)4C2N5H
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care 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: 03/31/2018
• Device Model Number: 70900-01
• Device Catalogue Number: 70932
• Device Lot Number: 4C2N5H
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 12/12/2017; 09/25/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 01/09/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1