MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CEA; CARCINOEMBRYONIC ANTIGEN

Catalog Number	07K68-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
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.
Event or Problem Description
The customer stated that a falsely decreased architect cea result was generated for a patient sample (id (b)(6)).The following data was provided: initial result: 316.60 ng/ml.Retest 1: 0.5 ng/ml.Retest 2: 315.32 ng/ml.Retest 3: 316.72 ng/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.No patient sample was available for investigation.Therefore, testing of serum based panel samples, which mimics patient sample, was performed using an in-house retained kit of lot 96159fn00 stored at the recommended storage condition.All specifications were met indicating that lot 96159fn00 is performing acceptably.Field data was reviewed which determined that the patient median result for the likely cause product lot is comparable with other lots in the field and confirms no systemic issue for the lot.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed, and no issues were identified.Based on the available information, no product deficiency was identified.

• Brand Name: ARCHITECT CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8809765
• Report Number: 3008344661-2019-00088
• Device Sequence Number: 16228903
• Product Code: DHX
• UDI-Device Identifier: 00380740112424
• UDI-Public: 00380740112424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990774
• 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): 10/16/2019

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: 07/16/2020
• Device Catalogue Number: 07K68-35
• Device Lot Number: 96159FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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; ARCHITECT I2000SR ANALYZER; LIST 03M74-01, SERIAL (B)(4); LIST 03M74-01, SERIAL (B)(4)