MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Historical performance of the clin chem creatinine assay (list 3l81) was evaluated using world wide data from abbott link.This review confirms no issues for this assay and shows the patient median results are neither increased nor decreased.The customer's architect c8000 serial number (b)(4) logs were reviewed.The result log showed an atypical absorbance graph for the result.The history log shows cuvette washer errors near the time of the erroneous sample results were reported.The maintenance log shows a failure of the wash cuvettes weekly maintenance procedure on the same day, near the time the suspect creatinine result was produced.There were no other complaints received for the creatinine reagent lot 91746un15.There were no trends for ln 3l81 identified.A review of manufacturing records shows the product met specifications at the time of manufacture.A review of labeling shows sufficient information on how to identify, troubleshoot and correct the issue.The initial creatinine result was flagged as "high" by the instrument and should have been repeated before being reported.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Use error may have contributed to the customer's issue as cuvette wash errors indicate dirty cuvettes which may contribute to false results.However, a systemic issue and/or product deficiency was not identified.
Event or Problem Description
The customer stated that the architect analyzer generated falsely elevated creatinine results on one oncology department patient in (b)(6) 2016.The results provided were: initial = 4.7 / repeated = 1.5 (normal range 0.7-1.2).There was no additional patient information provided.There was no reported impact to patient management.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6569269
• Report Number: 1628664-2017-00218
• Device Sequence Number: 1089136
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K981799
• 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
• Report Date (Section B): 05/16/2017

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: 05/23/2017
• Device Catalogue Number: 03L81-32
• Device Lot Number: 91746UN15
• 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: 05/16/2017
• 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 C8000 SYSTEM, LIST # 01G06-11,; SERIAL # (B)(4)