MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY CREATININE

Catalog Number 03L81-32

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6623691
• MDR Text Key: 77317712
• Report Number: 1415939-2017-00130
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Catalogue Number: 03L81-32
• Device Lot Number: 36678UN15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1