MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Model Number	3L81-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
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.Complete information section a patient information; (b)(6).
Event or Problem Description
The customer reported a falsely elevated creatinine result on one male patient which was questioned by the physician.The results provided were: (b)(6) initial = 6.78 mg/dl (normal range 0.7-1.3 mg/dl).The patient had a kidney ultrasound without iv contrast and a urinalysis, which were both normal.A new sample drawn ((b)(6)) generated results of 1.06 / 1.09 mg/dl.The original sample was retested = 1.01 / 1.04 / 1.01 mg/dl and the original result was corrected to 1.01 mg/dl.There was no adverse impact to the patient reported.The patient received no additional treatment.
Additional Manufacturer Narrative
A review of the architect analyzer result log did not find the discrepant result (sid (b)(6)) of 6.78mg/dl, however, the repeat sample (sid (b)(6)) results of 1.06 and 1.09 mg/dl were found.The architect history log shows multiple occurrences of aspiration errors (error code 3375) and twelve cuvette-washing not completed errors (error code 0550) during the time of the discrepant result.The maintenance log confirms that the 6052 wash cuvettes procedure was not performed after the twelve occurrences of the 0550 error code.A review of the architect system operations manual shows adequate information for maintaining optimal system performance and provides guidance: probable causes and corrective actions for erratic results, poor precision, and error codes including the wash cuvettes procedure.A review of tickets did not identify any similar complaints and no trends for the reported issue.A review of the manufacturing documentation did not identify any issues associated with the customer observation.Based on the investigation no product deficiency was identified for the creatinine, list number 3l81, lot 95639un17.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6989909
• Report Number: 1628664-2017-00406
• Device Sequence Number: 518626
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: (01)00380740005993
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K981799
• 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): 11/13/2017

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: 09/01/2018
• Device Model Number: 3L81-32
• Device Catalogue Number: 03L81-32
• Device Lot Number: 95639UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1