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	02/08/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed a falsely depressed glucose result for a diabetic male patient generated from an architect c8000 analyzer and provided the following data: on (b)(6) 2023, sample id (b)(6): initial result was 16 mg/dl, repeat result was 16 mg/dl.The patient was tested in another laboratory the same day and the glucose result was 180 mg/dl (method unknown).It was reported that all glucose testing was not a fasting glucose test.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation regarding depressed result of architect glucose reagent lot number 62901uq10 assay 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.Ticket search by lot 62901uq10 did not identify an increase in complaint activity for the reported issue.Ticket and trending review did not identify any trends regarding for the identified product related to the reported issue.Return testing was not completed as returns were not available.File sample analysis was not performed as the issue appears to be specific to the documented patient sample.Quality control was in range on date of discrepant result, indicating the assay is performing as expected.Device history record review did not identify any nonconformances or deviations associated with the identified product and complaint issue.A labeling review determined product labeling provides adequate information regarding the customer issue.Based on the investigation, no systemic issue or deficiency with the architect glucose reagent lot number 62901uq10 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: 16454982
• Report Number: 3002809144-2023-00097
• Device Sequence Number: 5844657
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 10/31/2023
• Device Model Number: 3L82-22
• Device Catalogue Number: 03L82-22
• Device Lot Number: 62901UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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 C8 PROC MOD, 01G06-11, C804222; ARC C8 PROC MOD, 01G06-11, C804222
• Patient Sex: Male