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

Catalog Number	33820
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System performance indicators were acceptable at and around the time of this event.However, the available information reasonably suggests that the system has malfunctioned as information from competitor devices suggest the beckman coulter device did not perform as intended.There is no indication that the device was returned for evaluation.
Event or Problem Description
The customer reported obtaining reproducibly elevated tsh (thyroid stimulating hormone) results for one patient on the laboratory's unicel dxi800 access immunoassay system (serial number (b)(4)).The results were determined to be discordant with reproducibly lower tsh results obtained for the same patient by alternate methods (roche, siemens and abbot).Customer-provided data indicate that elevated access tsh resutls were also generated for this patient on an alternate unicel dxi800 access immunoassay system (serial number (b)(4)) and access2 immunoassay system (serial number (b)(4)).The customer reported that the patient had been inappropriately diagnosed with and treated for hypothyroidism due to the elevated erroneous tsh results.The customer indicated that the patient had been inappropriately prescribed the maximum dosage of levothyroxine.The customer did not indicate sample type but did relate that samples were centrifuged for 10 minutes at 3500 rpm (rotations per minute).The customer reported that tsh qc (quality control) results generated on the system had been acceptable.

• 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: 6547617
• Report Number: 2122870-2017-00032
• Device Sequence Number: 16165731
• 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
• Report Date (Section B): 05/04/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/05/2017
• 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
• Patient Age: 55 YR