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

Model Number 3L81-22

Device Problem High Test Results (2457)

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

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated creatinine results generated on the architect c8000 processing module for a (b)(6) year old male patient.The following data was provided (reference range: 62 to 120 umol/l): on (b)(6) 2020; sid: (b)(6); initial result = 183.8 umol/l, repeat = 186.3 umol/l, repeat on cobas = 85.1 umol/l, repeat on (b)(6) 2020 = 75 umol/l.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for lot number 20993un19.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the creatinine assay for lot number 20993un19 was identified.

• Brand Name: CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9938987
• MDR Text Key: 213411432
• Report Number: 3016438761-2020-00030
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

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: 08/13/2020
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 20993UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 PROCESSING MODULE,; ARCHITECT C8000 PROCESSING MODULE,; LIST 01G06-11, SERIAL (B)(6) ; LIST 01G06-11, SERIAL (B)(6)
• Patient Age: 53 YR