MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE

Model Number 7D63-21

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.

Event Description

The customer reported falsely depressed creatine kinase (ck) on one patient generated on the architect analyzer.The results provided were: auto dilution 1:10 = 477.4iu/l / manual dilution 1:10 =32619.1iu/l.There was no reported impact to patient management.

Manufacturer Narrative

Through troubleshooting, the customer replaced the physiological saline in the r1 reagent chamber, which resolved the issue.Return testing was not completed as returns were not available.A review of tickets determined normal complaint activity for lot 07560ui19, and no trends were identified for the product for the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the architect system operations manual provides multiple probable causes and corrective actions for controls being out of range or depressed concentration.The issue was caused by the saline in the r1 reagent chamber and not the creatine kinase reagent.Based on the investigation no product deficiency was identified for the creatine kinase, lot 07560un19.Correction to d suspect medical device, 4.Exp date from 01jan2020 to 02jan2020.

• Brand Name: ARCHITECT CREATINE KINASE
• Type of Device: CREATINE KINASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9446774
• MDR Text Key: 219840123
• Report Number: 1628664-2019-00751
• Device Sequence Number: 1
• Product Code: CGS
• UDI-Device Identifier: 00380740012878
• UDI-Public: 00380740012878
• Combination Product (y/n): N
• PMA/PMN Number: K983070
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Model Number: 7D63-21
• Device Catalogue Number: 07D63-21
• Device Lot Number: 07560UN19
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM, LN 03L77-01,; ARCHITECT C16000 SYSTEM, LN 03L77-01,; SERIAL # (B)(6); SERIAL # (B)(6)