MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY I CA 19-9XR; CA19-9

Catalog Number 08P32-20

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 08p32-20, that has a similar us product distributed in the us, list 08p32-21 and 08p32-31.Patient information: no further information is available.Investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing and a review of labeling.Review of tracking and trending reports for the alinity i ca 19-9xr assay did not identify any related trends.An increase in complaint activity associated with the complaint issue was identified for reagent lot 98368fp00.Return testing was not completed as returns were not available.An internal panel was tested with retained kits of reagent lot 98368fp00.Acceptance criteria was met, which indicates acceptable product performance.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity i ca 19-9xr assay was identified.

Event Description

The customer observed erratic/inconsistent alinity i ca 19-9xr results.The customer indicated a patient has been regularly monitored with consistently increasing ca 19-9 results that ranged from 42 to 647 u/ml.The customer reported that the undiluted result did not match diluted results for the samples collected in august and september.August 2019 sample id 1908330741: undiluted 1164 u/ml and diluted 1:10 278 to 364 u/ml.September 2019 sample id unknown: undiluted 1048 u/ml and diluted 1:10 456 u/ml.No impact to patient management was reported.

• Brand Name: ALINITY I CA 19-9XR
• Type of Device: CA19-9
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9411098
• MDR Text Key: 190120543
• Report Number: 3002809144-2019-01010
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2020
• Device Catalogue Number: 08P32-20
• Device Lot Number: 98368FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1