MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number	03L82-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
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 account generated a falsely depressed architect glucose of 10 mg/dl on a sample that repeated 143 mg/dl on another analyzer.The sample was processed again on the original analyzer with architect glucose of 145 mg/dl.No specific patient information or impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined there were no other complaints for likely cause lot 49673uq07.Tracking and trending report review for the architect glucose assay determined that there are no related adverse or non-statistical trends.Manufacturing release documents were reviewed and all specifications were met prior to release.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect glucose assay was identified.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6637410
• Report Number: 1628664-2017-00256
• Device Sequence Number: 105886
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 07/31/2017
• Device Catalogue Number: 03L82-41
• Device Lot Number: 49673UQ07
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 06/29/2017
• 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: LIST (B)(4) SERIAL (B)(4)