MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C GLUCOSE REAGENT KIT; HEXOKINASE, GLUCOSE

Catalog Number	07P55-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
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.
Event or Problem Description
The customer reported falsely elevated alinity c glucose result generated by the alinity c processing module for a patient with acute kidney failure.The sample generated error 1039 (unable to calculate result.Absorbance exceeded optical limits).The lab tech then performed an automatic dilution which generated a result of 1,867 mg/dl.This result was released out of the lab and questioned by the physician as it was inconsistent with the results from the point-of-care device.The following data was provided: customer¿s reference range: 70 to 109 mg/dl.Sid (b)(6): on (b)(6)2025 @20:53 pm initial result = no result (exception error 1039), repeat #1 (undiluted) = no result (exception error 1039), repeat #2 (undiluted) = no result (exception error 1039), repeat #3 automatic dilution (1:5) result = 1,867 mg/dl, repeat #5 (undiluted) = no result (exception error 1039), repeat #6 (undiluted) = no result (exception error 1039), repeat #7 manual dilution = no result (exception error 1039).Glucose results before and after: on (b)(6) 2025 @16:40 pm result = 96 mg/dl, on (b)(6) 2025 @03:13 am result = 93 mg/dl.Glucose results from point-of-care: 97 mg/dl, 101 mg/dl, 100 mg/dl.The customer pulled the same sample and repeated it three times (undiluted and 1:5 dilution) obtaining no result due to exception error 1039.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation 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 repeat testing obtained acceptable result.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review did not identify an increase in complaint activity.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c glucose reagent lot 66574uq06 was identified.
Event or Problem Description
The customer reported falsely elevated alinity c glucose result generated by the alinity c processing module for a patient with acute kidney failure.The sample generated error 1039 (unable to calculate result.Absorbance exceeded optical limits).The lab tech then performed an automatic dilution which generated a result of 1,867 mg/dl.This result was released out of the lab and questioned by the physician as it was inconsistent with the results from the point-of-care device.The following data was provided: customer¿s reference range: 70 to 109 mg/dl.Sid (b)(6): on (b)(6) 2025 @20:53 pm initial result = no result (exception error 1039), repeat #1 (undiluted) = no result (exception error 1039), repeat #2 (undiluted) = no result (exception error 1039), repeat #3 automatic dilution (1:5) result = 1,867 mg/dl, repeat #5 (undiluted) = no result (exception error 1039), repeat #6 (undiluted) = no result (exception error 1039), repeat #7 manual dilution = no result (exception error 1039).Glucose results before and after: on (b)(6) 2025 @16:40 pm result = 96 mg/dl, on (b)(6) 2025 @03:13 am result = 93 mg/dl.Glucose results from point-of-care: 97 mg/dl, 101 mg/dl, 100 mg/dl.The customer pulled the same sample and repeated it three times (undiluted and 1:5 dilution) obtaining no result due to exception error 1039.There was no impact to patient management reported.

• Brand Name: ALINITY C GLUCOSE REAGENT KIT
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21431204
• Report Number: 3002809144-2025-00049
• Device Sequence Number: 11933217
• Product Code: CFR
• UDI-Device Identifier: 00380740135454
• UDI-Public: (01)00380740135454(17)250630(10)66574UQ06
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 06/30/2025
• Device Catalogue Number: 07P55-30
• Device Lot Number: 66574UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown