MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2017
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.
Event or Problem Description
The account generated falsely elevated architect creatinine of 2.93 mg/dl on sample id (b)(4) that repeated 0.90 mg/dl.No specific patient information was provided.
Additional Manufacturer Narrative
Tracking and trending report review for the architect creatinine assay determined that there are no related adverse or non-statistical trends.Review of complaint activity for likely cause lot 22632un16 determined that there were no other complaints.Service visited the site and noted that there was creamy-looking residue found on the wash station mixer.Service also noted that detergent b on the instrument needed to be replaced.The history log from the customer's architect analyzer was reviewed and showed multiple error codes of 0550 (cuvette washing not completed, hardware failure or user pressed stop.Promptly perform the wash cuvettes procedure) and 3375 (unable to process test, aspiration error occurred).These error codes were present back to (b)(6) 2016 and (b)(6) 2016, respectively; and continued up to (b)(6) 2017 for both error codes.Labeling was also reviewed and sufficiently addresses the customer's issue.Based on the information within the complaint record, the device (creatinine reagent lot 22632un16, ln 3l81) 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.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6643041
• Report Number: 1628664-2017-00258
• Device Sequence Number: 16366913
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: (01)00380740005979(17)180529(10)22632UN16
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 06/26/2017

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: 05/29/2018
• Device Catalogue Number: 03L81-22
• Device Lot Number: 22632UN16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 06/26/2017
• 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: LIST (B)(4), SERIAL (B)(4)