MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number	03L82-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier of multiple is 3 patient ids: (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.H3 other text : an evaluation is in process.
Event or Problem Description
The account generated falsely elevated architect glucose results on 3 patient samples processed on the architect c4000 analyzer.Id (b)(6) generated architect glucose of 223 mg/dl that repeated 77 mg/dl.Id (b)(6) generated architect glucose of 384 mg/dl that repeated 74 mg/dl.Id (b)(6) generated architect glucose 219 mg/dl that repeated 98 mg/dl.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
The glucose reagent package insert provides information on reagent handling, and how it could impact results.Section 7 of the architect system operations manual, under operational precautions and limitations provides guidance for assay results in regards to symptoms, other test results, clinical impressions and other diagnostic procedures that must be considered for patient care management.Section 5 provides information and guidelines for maintaining optimal system performance, and section 10 provides probable causes and corrective actions for erratic results, poor precision and error codes.There were no other similar complaints with discrepant results identified for this reagent lot.There were no adverse trends identified.No systemic issue or product deficiency 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: 6498489
• Report Number: 1628664-2017-00113
• Device Sequence Number: 994847
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: (01)00380740006006(17)170831(10)49897UQ08
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 06/05/2017

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: 08/31/2017
• Device Catalogue Number: 03L82-21
• Device Lot Number: 49897UQ08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1