MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE

Model Number	7D63-21
Medical Device Problem Code	Low Test Results (2458)
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.There is no further patient information provided due to privacy issues.
Event or Problem 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.
Additional 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
• Common Device Name: CREATINE KINASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9446774
• Report Number: 1628664-2019-00751
• Device Sequence Number: 2432096
• Product Code: CGS
• UDI-Device Identifier: 00380740012878
• UDI-Public: 00380740012878
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983070
• 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): 02/03/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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 C16000 SYSTEM, LN 03L77-01,; ARCHITECT C16000 SYSTEM, LN 03L77-01,; SERIAL # (B)(6); SERIAL # (B)(6)