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

Model Number	3L82-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample id's (b)(6).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 falsely decreased blood glucose results generated from an architect c16000 analyzer.The customer reported that the glucose reagent kit was in one slot of the analyzer, however the analyzer identified it in a different slot.The customer provided the following data: sample id (b)(6): initial result = 55 mg/dl, repeat result = 179 mg/dl sample id (b)(6): initial result = 30 mg/dl, repeat result = 122 mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
Section b5 updated due to inclusion of additional samples impacted due to the glucose reagent issue.
Event or Problem Description
After further review, the following additional samples were impacted due to the glucose reagent being misread by the architect c16000 processing module¿s barcode reader (results in mg/dl): sample id (b)(6) initial result was 49, repeated result was 95.Sample id (b)(6) initial result was 61, repeated result was 86.Sample id (b)(6) initial result was 50, repeated result was 87.Sample id (b)(6) initial result was 54, repeated result was 136.Sample id (b)(6) initial result was 62, repeated result was 90.Sample id (b)(6) initial result was 70, repeated result was 86.Sample id (b)(6) initial result was 69, repeated result was 104.Sample id (b)(6) initial result was 52, repeated result was 80.Sample id (b)(6) initial result was 57, repeated result was 101.Sample id (b)(6) initial result was 54, repeated result was 89.Sample id (b)(6) initial result was 54, repeated result was 85.Sample id (b)(6) initial result was 63, repeated result was 95.Sample id (b)(6) initial result was 53, repeated result was 74.Sample id (b)(6) initial result was 68, repeated result was 86.Sample id (b)(6) initial result was 68, repeated result was 81.Sample id (b)(6) initial result was 68, repeated result was 84.Sample id (b)(6) initial result was 73, repeated result was 90.Sample id (b)(6) initial result was 34, repeated result was 98.Sample id (b)(6) initial result was 51, repeated result was 72.Sample id (b)(6) initial result was 64, repeated result was 134.Sample id (b)(6) initial result was 39, repeated result was 110.Sample id (b)(6) initial result was 45, repeated result was 67.The glucose reagent was loaded into position a7 and the cholesterol reagent was loaded in position a8.The reagent packs were not scanned by the barcode reader and the instrument thought the glucose reagent was loaded in position a8.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation regarding falsely decreased result for architect glucose reagent lot number 61633uq03 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.Return testing was not completed as returns were not available.Ticket search by lot 61633uq03 indicates that the reagent lot has normal complaint activity for this product.Ticket and trending review did not identify any related trends for the identified product.Device history record review did not identify any related non-conformances or deviations regarding the associated lot 61633uq03 and complaint issue.During troubleshooting, it was reported that rescanning the reagent has resolved the 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 61633uq03 was identified.
Event or Problem Description
The customer observed falsely decreased blood glucose results generated from an architect c16000 analyzer.The customer reported that the glucose reagent kit was in one slot of the analyzer, however the analyzer identified it in a different slot.The customer provided the following data: sample id (b)(6): initial result = 55 mg/dl, repeat result = 179 mg/dl sample id (b)(6): initial result = 30 mg/dl, repeat result = 122 mg/dl.After further review, the following additional samples were impacted due to the glucose reagent being misread by the architect c16000 processing module¿s barcode reader (results in mg/dl): sample id (b)(6) initial result was 49, repeated result was 95.Sample id (b)(6) initial result was 61, repeated result was 86.Sample id (b)(6) initial result was 50, repeated result was 87.Sample id (b)(6) initial result was 54, repeated result was 136.Sample id (b)(6) initial result was 62, repeated result was 90.Sample id (b)(6) initial result was 70, repeated result was 86.Sample id (b)(6) initial result was 69, repeated result was 104.Sample id (b)(6) initial result was 52, repeated result was 80.Sample id (b)(6) initial result was 57, repeated result was 101.Sample id (b)(6) initial result was 54, repeated result was 89.Sample id (b)(6) initial result was 54, repeated result was 85.Sample id (b)(6) initial result was 63, repeated result was 95.Sample id (b)(6) initial result was 53, repeated result was 74.Sample id (b)(6) initial result was 68, repeated result was 86.Sample id (b)(6) initial result was 68, repeated result was 81.Sample id (b)(6) initial result was 68, repeated result was 84.Sample id (b)(6) initial result was 73, repeated result was 90.Sample id (b)(6) initial result was 34, repeated result was 98.Sample id (b)(6) initial result was 51, repeated result was 72.Sample id (b)(6) initial result was 64, repeated result was 134.Sample id (b)(6) initial result was 39, repeated result was 110.Sample id (b)(6) initial result was 45, repeated result was 67.The glucose reagent was loaded into position a7 and the cholesterol reagent was loaded in position a8.The reagent packs were not scanned by the barcode reader and the instrument thought the glucose reagent was loaded in position a8.There was no reported impact to patient management.

• 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: 16254151
• Report Number: 3002809144-2023-00054
• Device Sequence Number: 12112510
• Product Code: CFR
• UDI-Device Identifier: 00380740161590
• UDI-Public: 00380740161590
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/10/2023

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: 03/31/2023
• Device Model Number: 3L82-42
• Device Catalogue Number: 03L82-42
• Device Lot Number: 61633UQ03
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 05/02/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/24/2023; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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 C16K PRC MOD, 03L77-01, C1601305; ARC C16K PRC MOD, 03L77-01, C1601305; ARC C16K PRC MOD, 03L77-01, C1601305; CC CHOLESTEROL 3032T, 07D62-22, 44418UN21; CC CHOLESTEROL 3032T, 07D62-22, 44418UN21; CC CHOLESTEROL 3032T, 07D62-22, 44418UN21
• Patient Sex: Unknown