MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Model Number	3L82-41
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
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 observed falsely elevated glucose results while using the clinical chemistry glucose reagents.The following data was provided.Initial 30.1 mmol/l, repeat 5.6 mmol/l.The patient is a newborn and the test was done using a heel stick specimen.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, instrument log review, and labeling review.No adverse trend was identified for the customer's issue.Device history review did not identify any issues that may have caused the customer issue.Log review indicated the pressure profile of the specimen with elevated results appeared to show evidence of fibrin or excess sample adhering to the analyzer probe.Review of the reaction graph indicated more sample volume than the expected 2.0 ul was present in the specimen cuvette.Excess sample volume or presence of fibrin may have impacted the results.Labeling was reviewed, was found to be adequate, and contains information related to sample preparation to ensure no fibrin or clots are present in the sample.Infant heel sticks on prone to clotting due to the collection technique.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.Additional information included patient sid for section a.Patient information and section b.Adverse event or product problem 5.Describe event or problem.
Event or Problem Description
Update january 10, 2018.The initial result was associated with sid (b)(6) and the repeat result was associated with sid (b)(6).

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7076646
• Report Number: 1628664-2017-00505
• Device Sequence Number: 19109679
• Product Code: CFR
• UDI-Device Identifier: 00380740006013
• UDI-Public: (01)00380740006013(17)180531(10)51142UQ04
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: 05/31/2018
• Device Model Number: 3L82-41
• Device Catalogue Number: 03L82-41
• Device Lot Number: 51142UQ04
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1