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

Catalog Number 33820

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 04/07/2017

Event Type  Injury  

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 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
• 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 kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681330
• MDR Report Key: 6547617
• MDR Text Key: 74586344
• Report Number: 2122870-2017-00032
• 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
• Report Date: 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
• 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: 04/07/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2016
• 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
• Patient Age: 55 YR