MAUDE Adverse Event Report: ABBOTT GMBH GLUCOSE; HEXOKINASE, GLUCOSE

Model Number	3L82-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant glucose results generated from an architect c4000.It was reported that patients with a low glucose result generated from the architect analyzer were also tested with a point of care (poc) glucose machine, which generated results that reportedly agreed with the patient history.The customer provided the following data (unit of measure ¿ mg/dl): no sample id, date : (b)(6) 2023, architect result = 27, poc result = 128, repeat poc result = 128.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for a falsely decreased result of architect glucose reagent lot number 62066uq05 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Ticket search by lot 62066uq05 determined that there has not been an increase in complaint activity.Ticket and trending review did not identify any trends regarding the complaint issue or the associated product list number.Device history record review did not find any nonconformances or deviations associated with lot number 62066uq05, associated product list number, or complaint issue.There were no issues reported for quality control testing, indicating that the architect glucose reagent lot number 62066uq05 was performing as expected.A labeling reviewed determined product labeling provides appropriate information regarding the issue the customer described.Based on the investigation, no systemic issue or deficiency with the architect glucose reagent lot number 62066uq05 was identified.

• Brand Name: GLUCOSE
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16330763
• Report Number: 3002809144-2023-00079
• Device Sequence Number: 20530560
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 05/31/2023
• Device Model Number: 3L82-22
• Device Catalogue Number: 03L82-22
• Device Lot Number: 62066UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, (B)(6) ; ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown