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

Model Number 3L82-42

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely reduced glucose result generated on the architect c16000 analyzer on a patient.Results provided : sid (b)(6): (b)(6) 2022 initial result 20 mg/dl, repeat on another architect = 170 mg/dl.Repeated on this analyzer = 167.2 mg/dl and 175.1 mg/dl.Customer's reference range: 70-135 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there was no other complaint activity for glucose (ln 3l82).Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Sample preparation is crucial to the generation of correct results.The instrument has systems to help detect sample issue such as bubbles, fibrin, but it cannot protect against all sample issues.The most likely cause is a sample issue such as bubbles in the sample, small fibrin in the sample or bubbles in the reagent which impacted the results.Reanalysis later did not have the same conditions present which caused an acceptable result.Based on the investigation, no systemic issue or deficiency for the glucose was identified.Use error may have contributed to the customer¿s issue as the most likely causes are items which the operator is responsible for including sample preparation and instrument maintenance.Edited typo in section h10: creatinine to glucose.

Manufacturer Narrative

A review of tickets determined that there was no other complaint activity for creatinine (ln 3l82).Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Sample preparation is crucial to the generation of correct results.The instrument has systems to help detect sample issue such as bubbles, fibrin, but it cannot protect against all sample issues.The most likely cause is a sample issue such as bubbles in the sample, small fibrin in the sample or bubbles in the reagent which impacted the results.Reanalysis later did not have the same conditions present which caused an acceptable result.Based on the investigation, no systemic issue or deficiency for the glucose was identified.Use error may have contributed to the customer¿s issue as the most likely causes are items which the operator is responsible for including sample preparation and instrument maintenance.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• Brand Name: GLUCOSE
• Type of Device: 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: 14935823
• MDR Text Key: 298198219
• Report Number: 3002809144-2022-00231
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740161590
• UDI-Public: 00380740161590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 3L82-42
• Device Catalogue Number: 03L82-42
• Device Lot Number: 61309UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1601157; ARC C16K PRC MOD, 03L77-01, C1601157; ARC C16K PRC MOD, 03L77-01, C1601157