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 Consequences Or Impact To Patient (2199)
Date of Event	08/13/2017
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 healthcare professional reported receiving an inaccurately high reading on the adc blood glucose meter.Health professional reported receiving a meter reading of ">500 mg/dl" compared to a lab result of 169 mg/dl 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.The reported adc reading was obtained from a patient experiencing medical issues unrelated to diabetes.The reported issue did not cause or contribute to a death, serious injury or mistreatment.
Additional Manufacturer Narrative
The reported meter was returned and investigation and a new issue was observed.Performed visual inspection on returned meter and no issues were observed.Meter powered on with button depression and upon docking.Unable to perform control solution testing.The meter was unable to perform a bar code scan.During further investigation, a detached inductor on the pcb (printed circuit board) was observed.A readings issue was not observed.The complaint is not confirmed.
Event or Problem Description
A healthcare professional reported receiving an inaccurately high reading on the adc blood glucose meter.Health professional reported receiving a meter reading of ">500 mg/dl" compared to a lab result of 169 mg/dl 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.The reported adc reading was obtained from a patient experiencing medical issues unrelated to diabetes.The reported issue did not cause or contribute to a death, serious injury or mistreatment.

• 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: 6877685
• Report Number: 2954323-2017-06493
• Device Sequence Number: 1011381
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: (01)00093815709329(17)20180430(10)4C3V5H
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 03/08/2018

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: 04/30/2018
• Device Model Number: 70900-01
• Device Catalogue Number: 70932
• Device Lot Number: 4C3V5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR