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)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.
Event or Problem Description
The customer observed a falsely elevated creatinine result while using clinical chemistry creatinine assay.The customer provided the following data (customer provided reference range 0.72-1.25 mg/dl): initial result: 5.58 mg/dl.The patient was redrawn per the physicians request and a result of 1.05 mg/dl was generated.The original specimen was retested generating the following results: 1.0, 1.04 and 1.03 mg/dl due to the elevated result the patient was instructed to discontinue taking the medication metformin.The patient resumed taking their medication one day later.There was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint data, an instrument log review, a search for similar complaints, and a review of labeling.Return material was not available.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 clinical chemistry creatinine assay, list number 03l81, was identified.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6463558
• Report Number: 1628664-2017-00095
• Device Sequence Number: 591745
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 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): 05/01/2017

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: 12/27/2017
• Device Catalogue Number: 03L81-32
• Device Lot Number: 82312UN16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/01/2017
• 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 C16000 SYSTEM; LN 03L77-01, SN (B)(4)