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

Catalog Number 33820

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

The customer did not supply patient demographics such as the patient's exact date of birth or weight.(b)(6).A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's laboratory to assess instrument performance.There was no indication of hardware issues, system flags or issues with other assays.There is no indication that the customer sent the access hypersensitive tsh reagent pack(s) to bec for further evaluation.All performance indicators including quality controls (qc) and calibrations were operating within specifications at the time of the event.In conclusion, the cause of the reproducible elevated access hypersensitive tsh results could not be determined for this event.

Event Description

On (b)(6) 2016 the customer reported obtaining reproducible elevated human thyroid stimulating hormone (access hypersensitive tsh) results for one (1) patient over a period of three (3) months on the laboratory's unicel dxi 800 access immunoassay system serial number (b)(4).The patient was tested on (b)(6) 2016 and an elevated access hypersensitive tsh result was obtained.The customer noted that previously the patient had access hypersensitive tsh results within the normal reference range of the assay.On (b)(6) 2016 the patient was tested again using the access hypersensitive tsh assay on the same unicel dxi 800 access immunoassay system and another elevated result, above the normal reference range of the assay, was obtained.The patient was retested the next day, (b)(6) 2016, at an alternate location using a unicel dxi 800 access immunoassay system (serial number not provided) and an elevated result was also obtained.The same patient was tested again on (b)(6) 2016, at the same alternate location, using the unicel dxi 800 access immunoassay system (serial number not provided) and another elevated access hypersensitive tsh result, above the normal reference range of the assay, was obtained.Then on (b)(6) 2016 the same patient was tested at a third location using another unicel dxi 800 access immunoassay system (serial number 604368) and an elevated access hypersensitive tsh result, above the normal reference range of the assay, was obtained.On (b)(6) 2016 the customer reanalyzed the patient's (b)(6) 2016 sample on the original unicel dxi 800 access immunoassay system and obtained an elevated access hypersensitive tsh result above the normal reference range of the assay.This same sample was also reanalyzed at the third location using unicel dxi 800 access immunoassay system serial number (b)(4) and an access hypersensitive tsh result within the normal reference range of the assay was obtained.This same sample was also analyzed on an alternate methodology (abbott architect) which produced a much lower discordant thyroid stimulating hormone (tsh) result.The same day, another sample from the patient in question was tested for access hypersensitive tsh on the original unicel dxi 800 access immunoassay system and a result above the normal reference range of the assay was obtained.This same sample was then analyzed at the third location using unicel dxi 800 immunoassay system serial number (b)(4) and a lower result within the normal reference range of the assay was obtained.This sample was also analyzed on an alternate methodology (abbott architect) which produced a lower discordant tsh result.The elevated access hypersensitive tsh results were released from the laboratory.As a result of the elevated access hypersensitive tsh results obtained the patient's treatment was changed.The customer noted that the patient was administered treatment over an extended period of time.The exact type of treatment is unknown.System performance indicators such as assay quality controls (qc) and calibrations were performing within the laboratory's established ranges and the assay's performance specifications.There were no reports of issues with hardware, system flags or issues with other assays.The patient's samples were collected in 13x100mm collection tubes without an additive and with a gel separator.The samples were centrifuged for eight (8) to ten (10) minutes at 3,500 rpm (revolutions per minute) at a temperature of 25 degrees celsius.There were no reports of sample integrity issues in conjunction with this event.

• Brand Name: ACCESS HYPERSENSITIVE TSH 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: 5910783
• MDR Text Key: 53386508
• Report Number: 2122870-2016-00415
• Device Sequence Number: 1
• Product Code: JLW
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 33820
• Device Lot Number: 533451
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2015
• 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
• Patient Age: 71 YR