MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Catalog Number	03L82-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's device analysis results a search for similar complaints against glucose reagent lot 50158uq10 and the glucose assay did not identify any trends.Labeling was reviewed including the architect system and the glucose assay package insert adequately addresses the customer's issue.A log review of architect system serial number (b)(4) was performed.The instrument result log and pressure monitoring logs were reviewed.Reaction graph and pressure monitoring data reviews indicate a potential issue with the sample pipetting.Data points to the presence of a bubble in the sample responsible for a decreased sample volume and a lower result.No return sample was available and no file sample testing was performed.No non-conformances related to or similar to the current issue were identified.The lower glucose sample result was most likely due to a lower sample volume pipetted into the cuvette.Based on this evaluation the glucose assay and the architect system are performing acceptably.
Event or Problem Description
The account generated a falsely decreased architect glucose of 65 mg/dl on a patient that initially generated 537 mg/dl.Glucometer check was 460 and retest of the sample was 525 mg/dl.A new specimen generated similar results of 461 mg/dl on the architect and glucometer.No impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6428323
• Report Number: 1628664-2017-00079
• Device Sequence Number: 735471
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: (01)00380740006006(17)171031(10)50158UQ10
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 03/23/2017

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: 10/31/2017
• Device Catalogue Number: 03L82-21
• Device Lot Number: 50158UQ10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/23/2017
• 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: ARCHITECT C4000; LIST 02P24-40 SERIAL (B)(4)
• Patient Age: 61 YR