MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CLINICAL CHEMISTRY CREATININE

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: (b)(6).

Event Description

The customer reported a false elevated creatinine result on the architect c8000 processing module for a patient.The following data was provided: on (b)(6) 2020 sid (b)(6) = initial result = 2.51 mg/dl, on (b)(6) 2020 result = 0.70 mg/dl(new patient sample).There was no impact to patient management reported.

Manufacturer Narrative

A review of the ticket determined that there is normal complaint activity for reagent lot 33550un20.The trending review data determined no trends identified for the issue.Return testing was not completed as returns were not available.The customer observed a false elevated creatinine result when using creatinine reagent ln 3l81, lot 33550un20.Quality control (qc) was in range.The cbc sample for this patient also gave questionable results.The next day a new sample from the patient gave lower results for the assay.A review of the manufacturing documentation did not identify any issues associated with the complaint.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect creatinine reagent lot 33550un20.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10335171
• MDR Text Key: 232813908
• Report Number: 3016438761-2020-00145
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (y/n): N
• PMA/PMN Number: K981799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: N/A
• Device Catalogue Number: 03L81-22
• Device Lot Number: 33550UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 PROCESSING MODULE,; ARCHITECT C8000 PROCESSING MODULE,; GLUCOSE, LIST 03L82-22, LOT 55727UQ08; GLUCOSE, LIST 03L82-22, LOT 55727UQ08; LIST 01G06-11, SERIAL (B)(4).; LIST 01G06-11,SERIAL (B)(4),