MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Catalog Number	03L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Patient information: no further information was provided.
Event or Problem Description
The customer reported a falsely elevated architect creatinine result.Sample id (b)(6) generated initial 201 umol/l and retest 104 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the complaint issue included a review of the complaint text, review of trending reports, and review of labeling.Return testing was not completed as returns were not available.Tracking and trending report review for the architect creatinine assay did not identify any related trends.Manufacturing documentation for the assay did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect creatinine assay was identified.

• Brand Name: CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9071796
• Report Number: 1628664-2019-00613
• Device Sequence Number: 16776417
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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 Catalogue Number: 03L81-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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 C4000 ANALYZER,; ARCHITECT C4000 ANALYZER,; LIST 02P24-01, SERIAL (B)(4); LIST 02P24-01, SERIAL (B)(4)