MAUDE Adverse Event Report: BECKMAN COULTER ACCESS PROGESTERONE REAGENT; RADIOIMMUNOASSAY, PROGESTERONE

Catalog Number 33550

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

The customer did not supply patient demographics such as age, date of birth or weight.There is no evidence that the access progesterone reagent was returned for evaluation.A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site.No hardware malfunctions were reported that may have caused, or contributed to this event.There was no evidence to reasonably suggest an analyzer malfunction or reagent/calibrator performance issue.In conclusion, an assignable cause for this event cannot be confirmed with the available information.

Event Description

On (b)(6) 2016, the customer reported obtaining a low progesterone (access progesterone) result in association with their access 2 immunoassay system (serial number (b)(4)).The initial access progesterone recovery was below the expected result.This result was released from the laboratory.There was a report of a change to patient treatment which occurred in association with the low access progesterone result obtained on (b)(6) 2016.The patient was administered progesterone medication.No additional change in patient treatment or injury was reported.The same patient's sample was analyzed on an alternate analyzer, unicel dxi 800 access immunoassay system (serial number unknown) and recovered with similar results, below the expected reference range for this patient.A second sample was obtained from the patient on (b)(6) 2016 and was analyzed on a roche instrument and recovered with higher results, within the customer's expectations.The customer did not report issues with other assays.Information on quality control was not provided.No hardware errors, flags or other assay issues were reported in conjunction with this incident.The customer did not supply any information regarding the patient's sample collection and/or the speed, time, and temperature at which the sample was centrifuged.A beckman coulter (bec) field service engineer(fse) was dispatched to evaluate the instrument.

• Brand Name: ACCESS PROGESTERONE REAGENT
• Type of Device: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681330
• MDR Report Key: 5921117
• MDR Text Key: 53701705
• Report Number: 2122870-2016-00430
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 955769
• 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
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 33550
• Device Lot Number: 536965
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2016
• 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
• Patient Outcome(s): Other