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

Catalog Number	33820
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6651115
• Report Number: 2122870-2017-00033
• Device Sequence Number: 16526507
• Product Code: JLW
• UDI-Device Identifier: 15099590575311
• UDI-Public: (01)15099590575311(17)170930(11)160930(10)628864
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 33820
• Device Lot Number: 628864
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other