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

Catalog Number	02K45-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a (b)(6) female patient underwent a cat scan with iv contrast, an enteroscopy, and a gastroscopy based on falsely elevated ca 19-9 and ca125 results generated on the architect i2000sr analyzer.Results provided: sid (b)(6), (b)(6) 2019 ca 19-9 = >1200 u/ml / reference lab = <37 u/ml; sid (b)(6), (b)(6) 2019 ca125 = 126.4 u/ml / reference lab = <35 u/ml.The patient is doing well and there was no adverse impact to the patients health reported.
Additional Manufacturer Narrative
A review of complaints for architect ca19-9xr (list 2k91) and architect ca125 ii (list 2k45) assays determined that there are no trends for the product related to patient results.A review of the manufacturing documentation did not identify any issues associated with the customers observation.Historical performance in the field of reagent lots using world wide data through abbottlink was evaluated.The patient median result for lots 94014m800 (ca 19-9xr) and 93021m80 (ca125 ii) were analyzed and found to be within established baselines and confirms no systemic issues for these lots.Additionally, the patient sample was returned and tested at an outside reference laboratory for heterophilic antibodies on the ca 19-9 assay and was inconclusive for sample interference.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect ca19-9xr (lot 94014m800) and architect ca125 ii (lot 93021m80) assays.Refer to manufacturer report number 3002809144-2019-00423 for submission on ca 19-9xr list 2k91 lot# 94014m800.

• 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: 8776748
• Report Number: 1415939-2019-00136
• Device Sequence Number: 11218191
• Product Code: LTK
• UDI-Device Identifier: 00380740003388
• UDI-Public: 00380740003388
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042731
• 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): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: 02K45-20
• Device Lot Number: 93021M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(4) ; SERIAL (B)(4) ; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR