MAUDE Adverse Event Report: ABBOTT GERMANY 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
There was no additional patient information provided by the customer.This issue was previously reported under mdr number 1415939-2019-00040 under the incorrect manufacturing site.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.
Event or Problem Description
The customer reported falsely elevated architect ca125 results on one (b)(6) 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.

• Brand Name: ARCHITECT CA 125 II
• Common Device Name: OC 125 DEFINED ANTIGEN
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9342069
• Report Number: 3002809144-2019-00918
• Device Sequence Number: 2225143
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR