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

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication the access htsh reagent was returned for evaluation.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
The customer contacted beckman coulter on (b)(6) 2017 to report generating a non-reproducible elevated thyroid stimulating hormone (access htsh) results for one (1) patient on the unicel dxi 800 access immunoassay system serial number (b)(4).The patient's elevated access htsh sample was repeated on an alternate system (methodology unknown) and the result was reported to be normal.It was noted that additional thyroid assays (access freet3, access freet4, access total t3 and access total t4) were performed, for the same patient and all results, recovered with in each assay's normal reference range.There was change or impact to patient care or treatment, which occurred in association with the non-reproducible, elevated access htsh result; as the pregnant patient was administered medication.The customer did not provide sample collection information.Quality control (qc) and system check parameters were performing within assay and instrument specifications at the time of the 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: 6420832
• Report Number: 2122870-2017-00025
• Device Sequence Number: 537708
• Product Code: JLW
• UDI-Device Identifier: 15099590575311
• UDI-Public: (01)15099590575311(17)170731(11)160828(10)628552
• 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
• Report Date (Section B): 03/03/2017

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: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 33820
• Device Lot Number: 628552
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other