MAUDE Adverse Event Report: BECKMAN COULTER ACCESS HTSH REAGENT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 33820

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

The customer did not provide patient demographics such as: age, date of birth, or weight.A beckman coulter (bec) field service engineer (fse) was not dispatched.There is no indication that the access tsh reagent was returned for evaluation.In conclusion, the cause of this event cannot be determined with the supplied information.

Event Description

The customer reported obtaining a non-reproducible thyroid stimulating hormone (access tsh) result involving the unicel dxi 800 access immunoassay system serial number (b)(4) for one (1) patient.The patient's sample was repeated on an alternate analyzer, methodology unknown, and a lower result was obtained.The initial, elevated access tsh result was released from the laboratory.There was change or impact to patient care or treatment which occurred in association with the non-reproducible access tsh result as unknown medication was either started or stopped and unknown procedures were performed.Quality control (qc) and calibration were performing within the assay and instrument specifications at the time of the event.No information regarding sample collection or processing was provided by the customer.

Manufacturer Narrative

The patient was administered the medication levothyroxine due to the elevated access htsh results obtained.There were no further changes to treatment or patient management in conjunction with this event.

• Brand Name: ACCESS HTSH REAGENT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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 killian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681330
• MDR Report Key: 6651115
• MDR Text Key: 77915834
• Report Number: 2122870-2017-00033
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 15099590575311
• UDI-Public: (01)15099590575311(17)170930(11)160930(10)628864
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042281
• 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,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 33820
• Device Lot Number: 628864
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 06/22/2017
• Supplement Dates FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2015
• 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
• Patient Outcome(s): Other