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

Catalog Number	07P55-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) (complete sample id exceeded the amount of characters allowed in this field).All available patient information was included.Additional patient details are not available.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 decreased alinity c glucose results generated on the alinity c processing module for one patient with diabetes.The following data was provided: sid (b)(6): initial result = < 5 mg/dl a rapid blood glucose test was performed on the patient and the glucose result obtained was 240 mg/dl the sample was repeated on two other instruments present in the laboratory: instrument ac07153 repeated in duplicate and generated a result of < 5 mg/dl both times.Instrument (b)(6) repeated in duplicate on concentrated and diluted sample: result of undiluted sample = < 5 mg/dl.Result of diluted sample = < 25 mg/dl.The customer performed testing on a second sample from the diabetic patient: sample tube without gel sid (b)(6) result = 50 mg/dl (result being questioned) sample tube with gel sid (b)(6) result = 150 mg/dl (result considered in line with patient history) the measuring interval of the alinity c glucose assay serum/plasma application is 5 to 800 mg/dl.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, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search by lot 65381uq12 did not identify an increase in complaint activity related to the issue under review.Ticket trending review did not identify any trends.A review of the device history record did not identify any nonconformances or deviations associated with lot number 65381uq12 and the complaint issue.The historical performance of reagent lot number 65381uq12 was evaluated using worldwide data from customers in the field.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for the lot numbers in the field for lot number 65381uq12 is within the established control limits.Therefore, no unusual reagent performance was identified.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency was identified for alinity c glucose reagent lot 65381uq12.
Event or Problem Description
The customer reported falsely decreased alinity c glucose results generated on the alinity c processing module for one patient with diabetes.The following data was provided: sid (b)(6): initial result = < 5 mg/dl a rapid blood glucose test was performed on the patient and the glucose result obtained was 240 mg/dl.The sample was repeated on two other instruments present in the laboratory: instrument (b)(6) repeated in duplicate and generated a result of < 5 mg/dl both times.Instrument (b)(6) repeated in duplicate on concentrated and diluted sample: result of undiluted sample = < 5 mg/dl.Result of diluted sample = < 25 mg/dl.The customer performed testing on a second sample from the diabetic patient: sample tube without gel sid (b)(6) result = 50 mg/dl.(result being questioned) sample tube with gel sid (b)(6) result = 150 mg/dl.(result considered in line with patient history) the measuring interval of the alinity c glucose assay serum/plasma application is 5 to 800 mg/dl.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: 20042293
• Report Number: 3002809144-2024-00249
• Device Sequence Number: 18136845
• Product Code: CFR
• UDI-Device Identifier: 00380740135454
• UDI-Public: (01)00380740135454(17)241231(10)65381UQ12
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170316
• 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): 09/27/2024

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: 12/31/2024
• Device Catalogue Number: 07P55-30
• Device Lot Number: 65381UQ12
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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); ALNTY C PROCESSING MODU,03R67-01,(B)(6); ALNTY C PROCESSING MODU,03R67-01,(B)(6); ALNTY C PROCESSING MODU,03R67-01,(B)(6); ALNTY C PROCESSING MODU,03R67-01,(B)(6)
• Patient Sex: Unknown