MAUDE Adverse Event Report: ABBOTT LABORATORIES 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)
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 manufacturing review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Manufacturing review did not identify any issues that may have caused the customer issue.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not identified.
Event or Problem Description
The customer observed falsely elevated creatinine results generated using the architect clinical chemistry creatinine reagents.The following data was provided (mg/dl).Sid (b)(6) (tested in (b)(6) 2016) initial 2.1, retest 1.5, 1.5.Additional unopened specimen retest 0.9, 0.9.No impact to patient management was reported.
Additional Manufacturer Narrative
The medical device manufacturer was incorrect for this issue.Mdr number 1628664-2017-00382 has been submitted and all further information will be documented under that mdr number.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6623691
• Report Number: 1415939-2017-00130
• Device Sequence Number: 16146498
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/17/2017

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
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1