MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA125 II REAGENT KIT; TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Model Number	02K4529
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer stated that a falsely elevated architect ca 125 result of 40.72 u/ml was generated for a patient sample that retested at 25.21 u/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Health effect impact code: f26 component code: g01003 d8.Was this device serviced by a third party? no after further evaluation, the suspect medical device was changed from architect ca125 ii reagent kit, list 02k45-29 to architect i1000sr analyzer, list 01l86-01, on march 4, 2021.Mdr number 3016438761-2021-00096 has been submitted for the updated suspect medical device and all further information will be documented under that mdr number.See h10.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ARCHITECT CA125 II REAGENT KIT
• Common Device Name: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11330008
• Report Number: 3002809144-2021-00103
• Device Sequence Number: 19047091
• Product Code: LTK
• UDI-Device Identifier: 00380740145378
• UDI-Public: 00380740145378
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K042731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 08/20/2021
• Device Model Number: 02K4529
• Device Catalogue Number: 02K45-29
• Device Lot Number: 19016M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 06/07/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/17/2021; 06/08/2021
• 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: ARC I1000SR MOD, 01L86-01, I1SR01190; ARC I1000SR MOD, 01L86-01, I1SR01190; ARC I1000SR MOD, 01L86-01, I1SR01190