MAUDE Adverse Event Report: BECKMAN COULTER ACCESS CEA; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN, PRODUCT CODE: DHX

Catalog Number 33200

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

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex, and weight.(b)(6).A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site to assess the instrument's performance.The fse performed pressure sensor calibration; no hardware malfunctions were identified that may have caused, or contributed, to this event.The implicated reagent packs were discarded by the customer and are not available for investigation.Investigation of the event determined that an error occurred on the manufacturer's reagent pack fill line.Due to the error, partially filled reagent packs were released for use.When used to analyze patient samples, partially filled reagent packs could cause no value/qsd-flagged results.In conclusion, the cause of the no value/qsd-flagged access cea results is due to an error on the manufacturer's reagent pack fill line.(b)(4).

Event Description

The customer reported obtaining ten (10) no value/qsd-flagged (insufficient sample or reagent volume dispensed) carcinoembryonic antigen (access cea) patient results on the laboratory's unicel dxi 800 access immunoassay system, serial number (b)(4).The customer did not indicate if these samples were reanalyzed and what results they obtained if reanalysis did occur.Upon visual inspection, there were no signs of reagent pack leakage.None of the qsd-flagged access cea results were reported outside the laboratory.There was no change in patient treatment associated with this event.Calibration and quality control (qc) data were not provided for this event.The customer did not provide specific details regarding the patient samples or sample processing.There was no indication of sample integrity issues related to this event.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.

• Brand Name: ACCESS CEA
• Type of Device: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN, PRODUCT CODE: DHX
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318 1084
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318 1084
• Manufacturer Contact: jeffrey koll ; 1000 hazeltine drive; chaska, MN 55318-1084 ; 9523681361
• MDR Report Key: 5093776
• MDR Text Key: 26474782
• Report Number: 2122870-2015-00587
• Device Sequence Number: 1
• Product Code: DHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2016
• Device Catalogue Number: 33200
• Device Lot Number: 595027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2015
• 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