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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided evaluation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, and a review of labeling.Return material was not available from the customer.In-house testing performed across multiple architect csystem analyzers demonstrated that glucose reagent lot 48090uq08 is performing within specifications.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect tsh reagent, ln 03l82, lot 48090uq08, was identified.
Event or Problem Description
The customer observed a falsely decreased clincial chemistry glucose result while using the architect c4000 analyzer.The customer provided the following data: initial result: 709 mg/dl, retest 72 mg/dl.The physician questioned the result of 72 which did not align with the patient diagnosis and pathology (specific details not provided).A second specimen was drawn and generated result as expected; 707 mg/dl and 698 mg/dl there was no adverse impact to patient management 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: 6596501
• Report Number: 1628664-2017-00238
• Device Sequence Number: 16414777
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/29/2017

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: 08/31/2016
• Device Catalogue Number: 03L82-21
• Device Lot Number: 48090UQ08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 05/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1