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

Model Number	70907-03
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
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 the battery of an adc hospital blood glucose meter "exploded" while the meter was sitting on the docking station.The health care professional further reported that the meter was also "very hot to the touch." there was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The reported meter (b)(4) has been returned and investigated with retained batteries.Visual inspection has been performed on the returned meter; a corroded battery component was observed.Meter powered on with button depression and upon docking.The meter was sent for further investigation and during visual inspection, corrosion in the battery compartment along with contamination on the dock port was observed.The returned meter powered on properly with retained batteries.There is no evidence that an explosion occurred within the hardware of the meter.There has been no malfunction identified with a product designed by adc.Therefore this issue is not confirmed.Extended investigation has also been performed.The dhr (device history review) for the xceed meter was reviewed and showed the xceed meter passed all tests prior to release.No further investigation is required.
Event or Problem Description
A health care professional reported that the battery of an adc hospital blood glucose meter "exploded" while the meter was sitting on the docking station.The health care professional further reported that the meter was also "very hot to the touch." there was no report of a 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: 10934782
• Report Number: 2954323-2020-12524
• Device Sequence Number: 17208015
• Product Code: NBW
• UDI-Device Identifier: 00357599000189
• UDI-Public: 00357599000189
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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 Model Number: 70907-03
• Device Catalogue Number: 70907-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1