MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CA 125 II; OC 125 DEFINED ANTIGEN

Catalog Number	02K45-29
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
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 was no additional patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated architect ca125 results on one (b)(6) year old female diagnosed with ovarian serous cystic tumor.The results provided were: (b)(6) 2019 ca125 = 84.2u/ml / (b)(6) 2019 ovarectomy and surgery to remove tumor / (b)(6) 2019 ca125 = 295.5u/ml; on (b)(6) 2019 cea = 0.8 ng/ml and ca19-9 = 7.1 u/ml.There was no reported impact to patient management at this time.
Additional Manufacturer Narrative
A review of tickets did not identify any other complaints for lot 93028m800 for falsely elevated patient results.There were no trends identified for the product issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 93028m800 was evaluated using world wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 93028m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Use error may have contributed to the customer's issue as further testing of the patient sample indicated a possible interferent was present.Based on the investigation no product deficiency was identified for the architect ca125, lot 93028m800.
Additional Manufacturer Narrative
Manufacturing site of this report was incorrect (abbott laboratories, 100 abbott park road, abbott park, illinois, 60064) and a new mdr number 3002809144-2019-00918 has been submitted (correct site is abbott germany, max-planck-ring 2, wiesbaden, germany, 65205) and all further information will be documented under that mdr number.

• Brand Name: ARCHITECT CA 125 II
• Common Device Name: OC 125 DEFINED ANTIGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8693542
• Report Number: 1415939-2019-00040
• Device Sequence Number: 16608860
• Product Code: LTK
• UDI-Device Identifier: 00380740145378
• UDI-Public: 00380740145378
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: 02K45-29
• Device Lot Number: 93028M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 11/18/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/11/2019; 11/19/2019
• 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 I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # ISR54837; SERIAL # ISR54837; SERIAL # ISR54837
• Patient Age: 24 YR