MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-32
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2016
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, a search for similar complaints, labeling review, and device history review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.
Event or Problem Description
The product evaluation, closed on may 15, 2017, determined that a malfunction was identified, which impacts the previous reportability decision.The customer reported falsely elevated creatinine results for one patient generated using the clinical chemistry creatinine reagents.The following data was provided (mg/dl).Sid (b)(6) initial 7.60, repeat 0.7.No impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6595420
• Report Number: 1628664-2017-00237
• Device Sequence Number: 19068451
• 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): 05/26/2017

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: 03/14/2017
• Device Catalogue Number: 03L81-32
• Device Lot Number: 36678UN15
• 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: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1