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

Catalog Number 33200

Device Problem False Negative Result (1225)

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

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex, and weight.Initial the customer's telephone number is (b)(4).A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site to assess the instrument's performance.The fse checked the reagent pipettor and performed alignment; no hardware malfunctions were identified that may have caused, or contributed, to this event.The implicated reagent pack was discarded by the customer, so was 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 erroneous results.In conclusion, the cause of the erroneously low access cea results is due to an error on the manufacturer's reagent pack fill line.(b)(4).All related mdr reports: mdr 2122870-2015-00564, mdr 2122870-2015-00571, mdr 2122870-2015-00572, mdr 2122870-2015-00573, mdr 2122870-2015-00574, mdr 2122870-2015-00575, mdr 2122870-2015-00576.

Event Description

The customer reported obtaining seventeen (17) erroneously low carcinoembryonic antigen (access cea) results on the laboratory's access 2 immunoassay system, serial number (b)(4).The customer reanalyzed patient 1, patient 2, and patient 3 samples and obtained higher access cea results for all three (3) patients.Repeat results for patients 4 through 17 were not supplied.There were no signs of reagent pack leakage.The initial, low access cea results were not reported outside the laboratory.There was no change in patient treatment associated with this event.Calibrations were performing within assay and instrument specifications before and after this event.Quality control (qc) results were within established ranges before and after 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.This report will address two (2) of the patient results (designated as patient 9 and patient 10) obtained on (b)(6) 2015.Mdr 2122870-2015-00564 will address three (3) additional patient results (designated as patient 1, patient 2, and patient 3) obtained on (b)(6) 2015.Mdr 2122870-2015-00571 will address two (2) additional patient results (designated as patient 4 and patient 5) obtained on (b)(6) 2015.Mdr 2122870-2015-00572 will address three (3) additional patient results (designated as patient 6, patient 7, and patient 8) obtained on (b)(6) 2015.Mdr 2122870-2015-00574 will address three (3) additional patient results (designated as patient 11, patient 12, and patient 13) obtained on (b)(6) 2015.Mdr 2122870-2015-00575 will address two (2) additional patient results (designated as patient 14 and patient 15) obtained on (b)(6) 2015.Mdr 2122870-2015-00576 will address two (2) additional patient results (designated as patient 16 and patient 17) obtained on (b)(6) 2015.

• Brand Name: ACCESS CEA
• Type of Device: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• 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: 5068810
• MDR Text Key: 25515696
• Report Number: 2122870-2015-00573
• 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: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• 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