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 Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in section is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported that on (b)(6) 2018 at 3:43 p.M., she obtained a reading of 192 mg/dl on her adc meter that she felt was high.Customer further reported she "wasn't feeling well" and after leaving the doctor's clinic, she walked out of the building and experienced a loss of consciousness.Paramedics were called and upon their arrival within 5-10 minutes, a reading of 39 mg/dl was obtained on their device.Customer was treated with intravenous fluids "to bring (her) sugar up" and a peanut butter and jelly sandwich.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
No product has 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.The reported meter serial number (b)(4) was found to be invalid.The following dhr's have been performed for the corrected serial number (b)(4).Has been updated to reflect the valid meter serial number.A dhr (device history review) for the precision xtra was reviewed and the dhr showed the meter passed all tests prior to release.A dhr for the precision strips was reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed and all units performed within specification.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.This also serves as a correction report.(pma/510(k) #) was incorrectly documented in the initial 30 day report.Has been updated.
Event or Problem Description
Customer reported that on (b)(6) 2018 at 3:43 p.M., she obtained a reading of 192 mg/dl on her adc meter that she felt was high.Customer further reported she "wasn't feeling well" and after leaving the doctor's clinic, she walked out of the building and experienced a loss of consciousness.Paramedics were called and upon their arrival within 5-10 minutes, a reading of 39 mg/dl was obtained on their device.Customer was treated with intravenous fluids "to bring (her) sugar up" and a peanut butter and jelly sandwich.There was no report of death or permanent impairment 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: 7744668
• Report Number: 2954323-2018-05795
• Device Sequence Number: 19173887
• Product Code: NBW
• UDI-Device Identifier: 00093815998778
• UDI-Public: 00093815998778
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/26/2018

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: 04/30/2019
• Device Model Number: 98814-65
• Device Lot Number: 4500169708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 61