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

Model Number	98814-65
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 327 mg/dl, 497 mg/dl and 151 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.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
No product has been returned, extended investigation is pending at this time.A follow- up report will be submitted once additional information is obtained.The device manufacturer date for the reported meter is unknown.The date entered 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 receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 327 mg/dl, 497 mg/dl and 151 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.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.To date, product has not been returned for further investigation.The useful life of exceed meter is 4 years.As the manufacturing date of this product is before 2009, it has been in distribution beyond its useful life at the time of the complaint.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.Therefore, no further investigation activities are required for meter xce031-3323.Dhr for the precision strips were reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed for the precision strips and all units performed within specification.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 327 mg/dl, 497 mg/dl and 151 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.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Meter (b)(4) has been returned and investigated.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button depression and with strip insertion.Control solution testing was performed and no issues were observed.All results were within range specification.No malfunction or product deficiency was identified.If the reported test strips are returned, an investigation will be performed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.To date, product has not been returned for further investigation.The useful life of xceed meter is 4 years.As the manufacturing date of this product is before 2009, it has been in distribution beyond its useful life at the time of the complaint.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.Therefore, no further investigation activities are required for meter xce031-3323.Dhr for the precision strips were reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed for the precision strips and all units performed within specification.If the partial product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

• 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13239823
• Report Number: 2954323-2022-01316
• Device Sequence Number: 3927436
• Product Code: NBW
• UDI-Device Identifier: 00093815997283
• UDI-Public: 00093815997283
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2022

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: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: 98814-65
• Device Catalogue Number: 99728
• Device Lot Number: 4500184992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 05/26/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/15/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White