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

Model Number	3L82-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained falsely elevated glucose results while using the architect c4000 analyzer.On (b)(6) 2021, sample id (b)(6) generated a result of 382, and on the roche at an alternate hospital, 140.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the complaint issue included a review of complaint activity, trending data, device history records, labeling, and field data for the complaint lot.Review of trending data for the architect glucose assay did not identify any trends.Review of device history records did not identify any non-conformances related to the complaint issue.Labeling was reviewed and sufficiently addressed the customer's issue.Additionally, world wide field data for reagent lot 58873uq01 was evaluated.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 58873uq01 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Based on this investigation, no systemic issue or deficiency of the architect glucose lot was identified.
Additional Manufacturer Narrative
The customer provided the lot number in use.Therefore, sections d4 lot number, d4 expiration date and h4 device manufacture date were updated.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12609098
• Report Number: 3002809144-2021-00599
• Device Sequence Number: 11771887
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 11/23/2021

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: 01/31/2022
• Device Model Number: 3L82-22
• Device Catalogue Number: 03L82-22
• Device Lot Number: 58873UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/20/2021; 11/15/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/11/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, (B)(6).
• Patient Sex: Unknown