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

Model Number	98814-65
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer¿s wife reported customer received unspecified readings from his adc blood glucose meter that were believed to be erroneously high.She further reported that on (b)(6) 2019 customer experienced a loss of consciousness.Paramedics were called, treated him with an unspecified medication and transported him to a hospital.No additional information was provided as the caller declined to continue troubleshooting and disconnected the call.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported meter was returned and investigated with retained test strips.Visual inspection has been performed on the returned meter and no issues were observed.Control solution testing has been performed and no issues were observed, all result were within specification and no errors were observe during testing.The reported test strips have not been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Strip was not returned.Dhrs (device history review) for the precision strips were reviewed and the dhrs showed the precision strips meter passed all tests prior to release.  retain testing was performed for precision strips and all units performed in specification and passed.If the reported test strips are returned, an investigation will be performed.This also serves as a correction report.Section (pma510k#) was incorrectly documented in the initial mdr 30 day report.Section has been updated.
Event or Problem Description
Customer¿s wife reported customer received unspecified readings from his adc blood glucose meter that were believed to be erroneously high.She further reported that on (b)(6)2019 customer experienced a loss of consciousness.Paramedics were called, treated him with an unspecified medication and transported him to a hospital.No additional information was provided as the caller declined to continue troubleshooting and disconnected the call.There was no report of death or permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• 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: 8740585
• Report Number: 2954323-2019-05016
• Device Sequence Number: 11396646
• Product Code: NBW
• UDI-Device Identifier: 00093815996941
• UDI-Public: 00093815996941
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 98814-65
• Device Catalogue Number: 99694
• Device Lot Number: 4500180135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention