MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ULTRASENSITIVE HGH GROWTH HORMONE; RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Catalog Number 33580

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access hgh reagent was not returned for evaluation.A beckman coulter laboratory support specialist (lss) and a beckman coulter field service engineer (fse) were dispatched to the customer site.The lss and the fse did not report any hardware or system issues.System performance indicators such as system check and calibrations were passing within specifications according to the customer's verbal report.Per fse and lls report, quality control was also passing within specifications at the time of the incident.In conclusion, the root cause of the low hgh results could not be determined with the information provided.The beckman coulter internal identifier for this report is (b)(4).

Event Description

On (b)(6) 2019 the customer reported obtaining erroneous low hgh (access ultrasensitive hgh growth hormone) results (results not provided) for multiple patients (number of patients not specified) involving the laboratory's unicel dxi 800 access clinical system (part number 973100 and serial number (b)(4)).Dates of results obtained for patients were not provided.Prior to testing, patients had ultrasounds and x-rays performed; results of these did not indicate symptoms of nanism.Physician believed the access hgh results obtained from the unicel dxi 800 access clinical system were discordant with the ultrasounds and x-ray findings.The patients were provided drug therapy (information requested but not provided) due to the low hgh results obtained.The patient samples from which low access hgh results were obtained were then tested on the customer's alternate platform (siemens; further details not provided).The results obtained from testing on the customer's alternate platform (siemens) were noted to be higher (exact results not provided) and within reference range.The customer did not provide reference ranges.The beckman coulter reference ranges are: reference group: mean dose( ng/ml) , 95% reference interval.Female: 0.568, 0.010 - 3.607.Male: 0.113, 0.003 - 0.971.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.No information regarding sample collection tubes, centrifugation, sample storage or other information was provided.

• Brand Name: ACCESS ULTRASENSITIVE HGH GROWTH HORMONE
• Type of Device: RADIOIMMUNOASSAY, HUMAN GROWTH 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: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 9445138
• MDR Text Key: 186364149
• Report Number: 2122870-2019-01145
• Device Sequence Number: 1
• Product Code: CFL
• UDI-Device Identifier: 15099590231132
• UDI-Public: (01)15099590231132(17)200430(11)180501(10)831498
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 33580
• Device Lot Number: 831498
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2019
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other